NCT Number,Study Title,Study URL,Acronym,Study Status,Brief Summary,Study Results,Conditions,Interventions,Primary Outcome Measures,Secondary Outcome Measures,Other Outcome Measures,Sponsor,Collaborators,Sex,Age,Phases,Enrollment,Funder Type,Study Type,Study Design,Other IDs,Start Date,Primary Completion Date,Completion Date,First Posted,Results First Posted,Last Update Posted,Locations,Study Documents
NCT02667067,Investigation of the Simplify® Cervical Artificial Disc,https://clinicaltrials.gov/study/NCT02667067,,COMPLETED,This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.,YES,Cervical Degenerative Disc Disease,DEVICE: Simplify Disc|DEVICE: Anterior Cervical Discectomy & Fusion,"Number of Participants With Composite Clinical Success (CCS) of Simplify Disc, Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months.

Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months.

NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function., Baseline, 24 Months","Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery), Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function., Baseline, 3 Months|VAS Neck and Arm Pain, Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain), Baseline, 24 Months|Neurological Status, Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination., Baseline, 24 Months|SF-12 Physical Component Score (PCS) Maintenance or Improvement, The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.

Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design., Baseline, 24 Months|SF-12 Mental Component Score (MCS) Maintenance or Improvement, The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.

Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design., Baseline, 24 Months|Patient Questionnaires- Treatment Satisfaction Health Survey-, Question 1 - ""how does the subject rate satisfaction with the treated received"" was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied., 24 Months|Odom's Criteria Results, Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria., 24 Months|Dysphagia Handicap Index (DHI), Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100.

Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design., Baseline, 24 Months|Average Disc Height (Index Level), Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights., Baseline, 24 Months|Average Disc Height (Above the Index Level), Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights., Baseline, 24 Months|Average Disc Height (Below the Index Level), Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights., Baseline, 24 Months|Superior Adjacent Level Disc Degeneration, Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level., Baseline, 24 Months|Inferior Adjacent Level Disc Degeneration, Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level., Baseline, 24 Months|Device Migration, Device migration assesses significant movement of the implant postoperatively, Baseline, 24 Months|Facet Deterioration, Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline.

Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design., Baseline, 24 Months",,NuVasive,,ALL,ADULT,NA,150,INDUSTRY,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,G140154,2015-11,2020-03-23,2021-07-29,2016-01-28,2022-06-06,2022-06-30,"La Jolla, California, United States|Orange, California, United States|Santa Monica, California, United States|Thornton, Colorado, United States|Sarasota, Florida, United States|Evanston, Illinois, United States|Carmel, Indiana, United States|Paducah, Kentucky, United States|Shreveport, Louisiana, United States|Egg Harbor Township, New Jersey, United States|Lockport, New York, United States|Charlotte, North Carolina, United States|Addison, Texas, United States|Plano, Texas, United States|Tyler, Texas, United States|Reston, Virginia, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/67/NCT02667067/Prot_SAP_000.pdf"
NCT01860417,Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV),https://clinicaltrials.gov/study/NCT01860417,Disc_allo,COMPLETED,"In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, Investigational medicinal product Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).",YES,Degenerative Disc Disease|Intervertebral Disc Disease|Low Back Pain,BIOLOGICAL: Allogenic Mesenchymal Stromal Cells|DRUG: Mepivacaine,"Pain and Disability Evaluation, Change in the composite variable, which includes pain and disability 1 year after intervention, was plotted as a function of the initial pain score or disability index. Results for the relief of lumbar pain and Oswestry disability index were all included for both, control and cell-treated patients. The scores obtained from this analysis (slope of the plot) range from 0 to 1, with higher scores meaning a better outcome., Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention","Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months, Ratio discs density: Discs density at 12 months divided by discs density at 6 months after transplantation.

To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value., At 12 months from 6 months after the intervention|Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months, Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value., At 6 months after the intervention|Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months, Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value., At 12 months after the intervention|Visual Analogue Scale at 3 Months, Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity, At 3 months after the intervention|Visual Analogue Scale at 6 Months, Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity, At 6 months after the intervention|Visual Analogue Scale at 12 Months, Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity, At 12 months after the intervention|Oswestry Disability Index at 3 Months, Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible, At 3 months after the intervention|Oswestry Disability Index at 6 Months, Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible, At 6 months after the intervention|Oswestry Disability Index at 12 Months, Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible, At 12 months after the intervention|SF-12 Physical Component at 3 Months, Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 3 months after the intervention|SF-12 Physical Component at 6 Months, Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 6 months after the intervention|SF-12 Physical Component at 12 Months, Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 12 months after the intervention|SF-12 Mental Component at 3 Months, Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 3 months after the intervention|SF-12 Mental Component at 6 Months, Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 6 months after the intervention|SF-12 Mental Component at 12 Months, Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, 12 months after the intervention|Pfirrmann Stage at 6 Months, Grades:

Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased.

Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed, At 6 months after the intervention|Pfirrmann Stage at 12 Months, Grades:

Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased.

Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed, At 12 months after the intervention",,Red de Terapia Celular,Citospin|University of Valladolid,ALL,"ADULT, OLDER_ADULT",PHASE1|PHASE2,24,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",TerCel005|2012-004444-30|Disc_allo_MSV,2013-06-21,2015-12-15,2015-12-15,2013-05-22,2024-04-29,2024-04-29,"Hospital Clinico Universitario, Valladolid, 47003, Spain|Instituto de Biologia y Genetica Molecular, Valladolid, 47003, Spain","Study Protocol, Statistical Analysis Plan, and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/17/NCT01860417/Prot_SAP_ICF_000.pdf"
NCT03817606,A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant,https://clinicaltrials.gov/study/NCT03817606,,TERMINATED,The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.,YES,Degenerative Disc Disease|Degenerative Scoliosis,DEVICE: Tritanium Posterior Lumbar Cage|DEVICE: AVS UniLIF PEEK Posterior Lumbar Cage,"Number of Participants With Fusion Success, CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint, 12 Months","Change in Visual Analogue Scale, Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation|Change in Low Back Function, Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled)., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation|Change in Quality of Life: SF-36 PCS, Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function)., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.|Number of Participants That Return to Work, Subjects who were unable to work due to their back pain who return to work., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation|Ambulatory Status, Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation|Number of Participants With Serious Adverse Events, Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation, 6 weeks; 3 months; 6 months; and 12 months post operation|Change in Quality of Life: EQ-5d, Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health., Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation",,Riverside Medical Center,Stryker Spine,ALL,"ADULT, OLDER_ADULT",NA,4,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT,RMC193,2019-03-01,2020-06-30,2021-04-27,2019-01-25,2021-12-15,2023-01-10,"Riverside Medical Center, Kankakee, Illinois, 60901, United States","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/06/NCT03817606/Prot_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/06/NCT03817606/ICF_001.pdf"
NCT03018392,Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage,https://clinicaltrials.gov/study/NCT03018392,,COMPLETED,"The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.",YES,Intervertebral Disc Disease,DEVICE: Stryker Tritanium Spinal System,"Fusion Rate, Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion), 1 year",,,Bone and Joint Clinic of Baton Rouge,,ALL,"ADULT, OLDER_ADULT",NA,20,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,TRITANIUM,2017-01,2020-01-28,2020-01-28,2017-01-12,2022-09-07,2022-09-07,,"Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/92/NCT03018392/Prot_SAP_000.pdf"
NCT04272606,TXA in Spinal Fusion,https://clinicaltrials.gov/study/NCT04272606,,COMPLETED,"Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.",YES,Degenerative Disc Disease,DRUG: Tranexamic Acid|DRUG: Saline Solution|DIAGNOSTIC_TEST: Visual Acuity Exam|DIAGNOSTIC_TEST: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM),"Transfusion, The number of participants who had red blood cells (RBC) transfused:

1. Intraoperatively
2. Postoperatively (prior to discharge or at day 5, whichever occurred first)
3. Either Intraoperatively or Postoperatively, Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported|Blood Loss, Amount of blood loss:

1. Intraoperatively
2. Postoperatively (prior to discharge or at day 5, whichever occurred first)
3. Either Intraoperatively or Postoperatively, Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported|Delirium Occurrence, Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument., Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported","Delirium Severity, Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium), Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported|Change in Interleukin-6 Concentration., Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw., Preoperatively and 24 hours postoperatively|Length of Postoperative Stay Prior to Discharge, Length of postoperative stay prior to discharge in days, Days thru day of discharge",,Catherine R. Olinger,,ALL,"ADULT, OLDER_ADULT",PHASE2,123,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",201912099,2020-08-01,2023-06-12,2023-06-12,2020-02-17,2024-05-14,2024-12-12,"University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/06/NCT04272606/Prot_002.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/06/NCT04272606/SAP_003.pdf"
NCT02070484,"Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease",https://clinicaltrials.gov/study/NCT02070484,,TERMINATED,The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.,YES,Lumbar Degenerative Disc Disease|Spinal Stenosis|Spondylolisthesis|Spondylosis|Intervertebral Disk Displacement|Intervertebral Disk Degeneration|Spinal Diseases|Bone Diseases|Musculoskeletal Diseases|Spondylolysis,BIOLOGICAL: NuCel|BIOLOGICAL: Demineralized Bone Matrix,"Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., 12 months|Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., Baseline|Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., 1 month|Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., 2 months|Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., 3 months|Oswestry Disability Index, The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability., 6 months","Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion, CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion., 6 and 12 months",,OhioHealth,"NuTech Medical, Inc",ALL,"ADULT, OLDER_ADULT",NA,6,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT,OH2-13-0034,2014-02,2017-03-24,2017-03-24,2014-02-25,2018-08-27,2018-09-28,"Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Grant Medical Center, Columbus, Ohio, 43215, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/84/NCT02070484/Prot_SAP_000.pdf"
NCT02412735,Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain,https://clinicaltrials.gov/study/NCT02412735,MSB-DR003,COMPLETED,"This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.",YES,Degenerative Disc Disease,DRUG: Rexlemestrocel-L|DRUG: Rexlemestrocel-L + HA Mixture|DRUG: Placebo,"Overall Treatment Success: Bayesian Estimated Response Rate, Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 \[12 months post-treatment\] and 8 \[24 months post-treatment\]). The average response rate (proportion of participants with response presented as Bayesian estimate\[BE\]) was based upon the average of multiple Bayesian simulations., Up to 24 months","Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate, A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations., Up to 24 months|Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate, A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations., Up to 24 months|Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate, A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations., Month 24|Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate, A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations., Month 24|Effectiveness Based on Time to First Intervention Over 24 Months, The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented., Up to Month 24|Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate, A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations., Month 24","Mean Change From Baseline in Low Back Pain Visual Analog Scale (VAS) Score at 1, 3, 6, 12, 18, 24, and 36 Months, Pain intensity was recorded on a horizontal 100 mm VAS and measured as the distance in millimeters from the left origin of the horizontal VAS line and the point indicated by the participant as representing their level of pain. A horizontal 100 mm VAS anchored on the left with the words ""No Pain"" and on the right with the words ""Worst Possible Pain"", was used to measure low back pain intensity. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the participant to indicate the participant's level of pain. VAS ranges from 0 to 100, with higher scores indicating worst possible pain. A negative change from baseline indicates improvement., Months 1, 3, 6, 12, 18, 24, and 36","Mesoblast, Ltd.","Quintiles, Inc.",ALL,"ADULT, OLDER_ADULT",PHASE3,404,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",MSB-DR003,2015-03-06,2020-05-15,2021-06-15,2015-04-09,2022-01-18,2022-10-19,"Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, 35235, United States|Tennessee Valley Pain Consultants, Huntsville, Alabama, 35801, United States|Arizona Pain Specialists, Scottsdale, Arizona, 85258, United States|Physicians Research Group, Tempe, Arizona, 85284-2604, United States|TriWest Research Associates, LLC, El Cajon, California, 92020-4124, United States|Memorial Orthopaedics Surgical Group, Long Beach, California, 90806, United States|Newport Beach Headache and Pain, Newport Beach, California, 92660, United States|Institute for Regenerative Medicine and Clinical Research, Pasadena, California, 91105, United States|UC Davis Spine Center, Sacramento, California, 95816, United States|Orthopedic Pain Specialists, Santa Monica, California, 90403, United States|The Spine Institute, Santa Monica, California, 90403, United States|Summit Pain Alliance, Santa Rosa, California, 95401, United States|Integrated Pain Management, Walnut Creek, California, 94598, United States|Denver Back Pain Specialists, LLC, Greenwood Village, Colorado, 80111, United States|George Washington University Medical Center, Washington, District of Columbia, 20037, United States|Coastal Clinical Research Specialists, Fernandina Beach, Florida, 32034, United States|Shrock Orthopedic Research, LLC, Fort Lauderdale, Florida, 33316, United States|Holy Cross Orthopedics Institute, Oakland Park, Florida, 33334, United States|Emory Orthopaedics & Spine Center, Atlanta, Georgia, 30329, United States|Georgia Institute for Clinical Research, LLC, Marietta, Georgia, 30060, United States|Injury Care Medical Center, Boise, Idaho, 83713, United States|Millennium Pain Center, Bloomington, Illinois, 61701, United States|Otrimed Clinical Research, Edgewood, Kentucky, 41017, United States|Orthopedic Specialists of Louisiana, Shreveport, Louisiana, 71103, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|MAPS Applied Research Center, Shakopee, Minnesota, 55379, United States|Innovative Pain Care Center, Las Vegas, Nevada, 89129, United States|University Clinical Research, Somerset, New Jersey, 08873, United States|Ainsworth Institute of Pain Management, New York, New York, 10022, United States|Rochester Regional Health, Rochester, New York, 14626, United States|Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina, 28204, United States|On Site Clinical Solutions, LLC, Morrisville, North Carolina, 28117, United States|The Center for Clinical Research/ Carolinas Pain Institute, Winston-Salem, North Carolina, 27103, United States|Cleveland Clinic, Cleveland, Ohio, 44106, United States|DOC Clinical Research, Dayton, Ohio, 45432, United States|Clinical Investigations, LLC, Edmond, Oklahoma, 73013, United States|Orthopaedic and Spine Specialists, York, Pennsylvania, 17402, United States|RI Hospital-Comprehensive Spine Center, Providence, Rhode Island, 02903, United States|Clinical Trials of South Carolina, Charleston, South Carolina, 29406, United States|Greenville Pharmaceutical Research, Inc., Charleston, South Carolina, 29406, United States|Texas Back Institute, Plano, Texas, 75093, United States|Spine Team Texas, Southlake, Texas, 76092, United States|Precision Spine Care, Tyler, Texas, 75701, United States|Ericksen Research & Development, LLC, Bountiful, Utah, 84010, United States|the SMART Clinic, Draper, Utah, 84020, United States|Hope Research Institute, Saint George, Utah, 84790, United States|Virginia iSpine Physicians, PC, Richmond, Virginia, 23235, United States|Monash Medical Center, Clayton, Victoria, 3168, Australia","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/35/NCT02412735/Prot_SAP_001.pdf"
NCT02347410,Spineology Clinical Outcomes Trial: An IDE Investigation,https://clinicaltrials.gov/study/NCT02347410,SCOUT,COMPLETED,This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.,YES,Lumbar Degenerative Disc Disease,DEVICE: SIFS graft containment device,"Overall Success, The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes:

1. Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score).
2. Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score).
3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan
4. Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint.

For the study to be a success, 68% of subjects need to meet the above success criteria., 24 months",,"Mean Low Back Pain Score at 24-months Post-operative, A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of ""0"" represents ""No Pain"" and a score of ""100"" represents the ""Worst possible"" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit., 24 months|Mean Back Function Score at 24-months Post-operative, A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from ""0"" to ""100"" points. A score of ""0"" represents ""No disability"" and ""100"" represents ""Total disability"". A clinically meaningful difference is defined as a 15-point reduction when compared to pre-op. Success for this parameter is evaluated at the 24-month visit., 24 months|Mean Right Leg Pain Score at 24-months Post-operative, A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of ""0"" represents ""No Pain"" and a score of ""100"" represents the ""Worst possible"" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit., 24 months|Mean Left Leg Pain Score at 24-months Post-operative, A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of ""0"" represents ""No Pain"" and a score of ""100"" represents the ""Worst possible"" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit., 24 Months|Number of Participants With Bridging Bone Presence, Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status., 24 months|Number of Participants Experiencing a Device-Related Serious Adverse Event, Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE)., Intra-Op through 24-month interval|Number of Participants With a Neurological Maintenance or Improvement, Rate of subjects that were neurologically improved or maintained compared to baseline, 24 months|Number of Participants Working, Compared the number of participants working at 24-months to number of subjects working at baseline, 24 months|Number of Participants With Narcotic Pain Medication, Narcotic pain medication use for back pain was compared to baseline., 24 Months|Blood Loss, Blood loss (cc) reported for the surgical procedure., At the conclusion of the surgical procedure, an average of 2.6 hours|Duration of Surgery, Operative time (from incision to closure)., At the conclusion of the surgical procedure|Duration of Hospital Stay, Number of days subject was in the hospital (from admission to discharge)., From admission through discharge, an average of 2 days|Patient Satisfaction, Subjects rating their procedure as excellent or good, 24-Months","Spineology, Inc",,ALL,"ADULT, OLDER_ADULT",NA,102,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,62-180,2015-01-22,2020-01-22,2020-03-04,2015-01-27,2021-10-20,2021-10-20,"Florida Orthopaedic Associates, DeLand, Florida, 32720, United States|Spine Institute of Louisiana, Shreveport, Louisiana, 71101, United States|Thibodaux Regional Medical Center, Thibodaux, Louisiana, 70901, United States|Georgetown University Hospital, Clinton, Maryland, 20735, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States|Sports Medicine North, Peabody, Massachusetts, 01960, United States|Bronson Healthcare Methodist Hospital - Neuroscience Center, Kalamazoo, Michigan, 39007, United States|Mayo Clinic Hospital - College of Medicine, Rochester, Minnesota, 55905, United States|University at Buffalo/SUNY, Buffalo, New York, 14203, United States|University of Vermont Medical Center, South Burlington, Vermont, 05403, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/10/NCT02347410/Prot_SAP_000.pdf"
NCT02704689,AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY,https://clinicaltrials.gov/study/NCT02704689,APROPOS,TERMINATED,"This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.",YES,"Degenerative Disc Disease|Spondylolisthesis, Grade 1|Retrolisthesis",DEVICE: AccuLIF expandable TLIF cage,"Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays., Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays., 24 months|Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm., Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm., 24 months","Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration., Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration., Operative Visit|Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days., Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days., Peri-op|Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery., Surgical Outcomes: To measure the amount of blood loss at the time of surgery., Operative Visit|Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device., Medical Outcomes: Incidence of complications associated with the procedure and/or device., 24 months|Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings, Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings, 24 months|Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings., Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings., 24 months|Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings., Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings., 24 months|Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS)., Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS)., 24 months|Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations., Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations., 24 months|Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12., Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12., 24 months|Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments., Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments., 24 months|Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging., Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging., 24 months",,Stryker Spine,,ALL,"ADULT, OLDER_ADULT",NA,9,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,2015-L-001|510(k) 132505 & K143616,2016-06-08,2017-01-19,2017-01-19,2016-03-10,2018-04-24,2018-04-24,"University of Missouri Health Care, Columbia, Missouri, 65212, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/89/NCT02704689/Prot_SAP_000.pdf"
NCT02182843,Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn),https://clinicaltrials.gov/study/NCT02182843,VCBM/ACDF,COMPLETED,"The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.",YES,Cervical Disc Degenerative Disorder,BIOLOGICAL: Cellentra VCBM,"Change in NDI From Baseline, Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%., 12 months after device implantation","Number of Participants With Radiographic Success at 24 Months, Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system:

* Grade I (definite) - Fused with remodeling and trabeculae
* Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies
* Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft
* Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse.

Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months, 24 Months",,Zimmer Biomet,,ALL,"ADULT, OLDER_ADULT",NA,81,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,CS-092,2014-03,2018-01,2018-01,2014-07-08,2019-03-15,2019-03-15,"Barrow Neurological Associates, Phoenix, Arizona, 85013, United States|Fort Wayne Ortho, Fort Wayne, Indiana, 46804, United States|Orthopaedic Institute of Western KY, Paducah, Kentucky, 42001, United States|Ohio State University Wexner Medical Center, Columbus, Ohio, 43203, United States|The Rothman Institute, Philadelphia, Pennsylvania, 19107, United States|Spine Team Texas, Southlake, Texas, 75032, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/43/NCT02182843/Prot_SAP_000.pdf"
NCT03062657,An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine,https://clinicaltrials.gov/study/NCT03062657,,TERMINATED,This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.,YES,Cervical Degenerative Disc Disease|Radiculopathy|Myelopathy,DEVICE: PRESTIGE LP™ Cervical Disc,"Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum, The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation.

One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24., Preoperative, 6 weeks, and 12 months","Number of Participants Who Achieved Overall Success, The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met:

1. NDI score improvement of at least 15 points from baseline;
2. Maintenance or improvement in neurological status;
3. No serious AE classified as implant associated/related or implant/surgical procedure associated/related;
4. No secondary surgical procedure classified as a ""failure""., 3, 6, and 12 months|Number of Participants Who Achieved NDI Success, The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition:

Preoperative Score - Postoperative Score \> 15, 3, 6, and 12 months|Neck Pain and Arm Pain, Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain.

Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time.

The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly., Preoperative, 3, 6, and 12 months|Number of Participants Who Achieved Neurological Success, Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated., 3, 6, and 12 months|Number of Participants Who Underwent Secondary Surgery at Index Level, Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed., 3, 6, and 12 months",,Medtronic Spinal and Biologics,,ALL,"ADULT, OLDER_ADULT",NA,25,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,SD1701,2018-06-06,2023-01-27,2023-01-27,2017-02-23,2024-03-21,2024-04-05,"Todd H. Lanman, M.D., INC., Beverly Hills, California, 90210, United States|Beaumont Hospital, Royal Oak, Michigan, 48073, United States|Kellogg M.D., Brain & Spine, Portland, Oregon, 97806, United States|Lexington Brain and Spine, West Columbia, South Carolina, 29169, United States","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/57/NCT03062657/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/57/NCT03062657/SAP_001.pdf"
NCT03484403,Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease,https://clinicaltrials.gov/study/NCT03484403,,COMPLETED,"The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or neurogenic claudication.

The secondary objectives of the study are to evaluate if a back brace provides any additive benefit to usual care consisting of exercise and patient education in patients with CLBP due to degenerative disc disease.

Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and patient-reported functional measures in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy.

Hypothesis 1. Back brace in addition to usual care will provide statistically significant improvement in pain and functional measures compared to usual care alone.

Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will demonstrate clinically acceptable rates of adherence to brace wear instructions.",YES,Degenerative Disc Disease|Lumbar Spondylosis|Low Back Pain,OTHER: Lumbar back brace|BEHAVIORAL: Back school,"Pain Diary, Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes.

Average weekly pain scores were compared from baseline to 6 week mark., Change between baseline and each week for 6 weeks|Pain Disability Questionnaire, Measures how pain affects the patients lifestyle and participation in activities.

Ranges from 0-150. Higher values indicate worse outcome., These assessments were made at baseline (T₀), 6 wks (T₁), 12 wks (T₂), and 6 mos (T₃). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).|PROMIS Instrument Questionnaire, Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112, Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)|European Qualify of Life (EQ-5D) Questionnaire, Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10, Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)",,,Dallas VA Medical Center,Aspen Medical Products,ALL,"ADULT, OLDER_ADULT",NA,61,FED,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,15-088,2015-12-14,2019-09-10,2019-09-30,2018-03-30,2024-01-08,2024-01-08,,"Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/03/NCT03484403/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/03/NCT03484403/ICF_001.pdf"
NCT02626624,Safety and Efficacy of the CarboClear Pedicle Screw System,https://clinicaltrials.gov/study/NCT02626624,,COMPLETED,"The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.",YES,"Degenerative Disc Disease|Spondylolisthesis, Grade 1",DEVICE: Implantation of the CarboClear Pedicle Screw System,"Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab., Fusion was assessed at follow-up visits, starting at 6 months post operation.

Fusion is defined as:

1. Angular motion ˂ 3º; AND
2. Translational motion ˂ 3 mm; AND
3. Presence of continuous bridging bone between the involved motion segment, i.e.:

   * Presence of interbody (between endplates) bridging bone and absence of radiolucency \> 50%; OR
   * Presence of right posterolateral bridging bone; OR
   * Presence of left posterolateral bridging bone., 24 months|Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire, Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits.

The scale ranges from 0 mm (""No Pain"") to 100 mm (""Severe Pain""). Patients were instructed to draw a single line across the scale at the point that best described their level of pain.

Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months.

Eligible patients experienced preoperative low back and/or leg pain (debilitating pain that significantly disrupted daily physical activities) with a VAS score of ≥40 mm., 24 months|Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire, The Oswestry Disability Index (ODI) is a patient-reported questionnaire administered preoperatively and at follow-up visits. The ODI consists of ten questions focusing on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each question has six possible responses.

The response scale ranges from 0 to 5 points, with a lower score indicating better function and lower pain (0 points for full functionality with no or minimal pain; 5 points for inability to perform the function due to pain). The total ODI score is calculated by summing the individual question scores and dividing the total by the maximum possible score (50 if all questions are answered), yielding a percentage. ODI scores range from 0% to 100%, with lower percentages indicating reduced pain and disability.

The functional outcome measure was defined as an improvement of at least 15 points from baseline at 24 months., 24 months|Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level., 1. Worsening in neurological status (motor, sensory, reflex, straight leg raising, and tenderness assessments) and no new permanent neurological deficits present for at least 2 successive visits at or beyond 6 months (out to 24 months);
2. Device-related serious adverse events (SAEs) through 24 months;
3. Subsequent surgical interventions at the index level through 24 months., Throughout the study until 24 months","Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire, Subject's overall well-being (quality of life) was assessed preoperatively and at follow-up visits, using the 12-Item Short Form Health Survey (SF-12), which is a multipurpose short-form quality of life instrument with 12 questions selected from the SF-36 Health Survey. SF-12 questionnaire is designed to measure general health status from the patient's point of view. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health Scales within the SF-12 instrument. The MCS is a composite of the Vitality, Social Functioning, Role-Emotional and Mental Health Scales within the SF-12 instrument. The SF-12 is a normative based instrument. PCS and MCS are computed using the rating on 12 questions from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level., 24 months|Patient Satisfaction: Assessed Based on VAS Patient Questionnaire., Satisfaction was assessed at postoperative follow-up visits including at 24-month visit, using a 100 mm VAS (the anchor points are ""Completely Not Satisfied"" (0 mm) and ""Completely Satisfied"" (100 mm)).

Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits.

The scale ranges from 0 mm (""No Pain"") to 100 mm (""Severe Pain""). Patients were instructed to draw a single line across the scale at the point that best described their level of pain.

Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months., 24 months|Operation Time [Min], Operation time (skin-to-skin) was recorded for each subject., During operation (skin-to-skin)|Blood Loss During Operation [ml], The volume of blood loss during operation was recorded for each subject., During operation (skin to skin)",,CarboFix Orthopedics Ltd.,CarboFix Orthopedics Inc.,ALL,"ADULT, OLDER_ADULT",NA,57,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,CARBOCLEAR P_CLD 2492_US,2015-12-27,2022-12-28,2022-12-28,2015-12-10,2025-04-27,2025-04-27,"Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|The Brooklyn Hospital, Brooklyn, New York, 11201, United States|Crystal Clinic Orthopaedic Center, Akron, Ohio, 44333, United States|St. David's Round Rock Medical Center, Austin, Texas, 78705, United States|Herzliya Medical Center, Herzliya, 4685107, Israel|Meir Medical Center, Kefar Saba, Israel|Assuta Medical Center - Israel Spine Center, Tel-Aviv, Israel","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/24/NCT02626624/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/24/NCT02626624/ICF_001.pdf"
NCT01829997,Assessment of nanOss Bioactive 3D in the Posterolateral Spine,https://clinicaltrials.gov/study/NCT01829997,,COMPLETED,"Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process.

nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.",YES,Degenerative Disc Disease|Spinal Stenosis|Spondylolisthesis,DEVICE: nanOss Bioactive 3D BVF,"Number of Patients With Fusion, Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion., 12 months","Number of Participants With Improvement in Quality of Life, Number of participants with improvement in quality of life after surgery using the RAND-36 (a short form health survey). It is a 36 set of easily administered quality of life measures answered by the patient., 12 months|Number of Participants With Improvement in Pain Scores, Number of participants with improvement in pain scores after surgery using the Visual Analog Scale. The scale measured from (0) no pain to (10) unbearable pain., 12 months|Number of Participants With Decreased Usage of Pain Medication, Number of participants with decreased usage of pain medication after surgery, 12 months|Returning to Work, Time frame in which patient returned to work after surgery, 12 Months|Satisfaction With Surgery, Overall satisfaction with the procedure, 12 months",,"Pioneer Surgical Technology, Inc.",,ALL,"ADULT, OLDER_ADULT",NA,22,INDUSTRY,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,NB3D012012,2013-04,2018-04,2018-04,2013-04-11,2019-04-17,2019-04-17,"Hospital for Joint Disease, New York, New York, 10003, United States|Hospital for Special Surgery, New York, New York, 10021, United States|MUSC Neurosurgery & Spine Services, Charleston, South Carolina, 29425, United States|Milwaukee Spinal Specialists, Glendale, Wisconsin, 53212, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/97/NCT01829997/Prot_SAP_000.pdf"
NCT03077204,BIO4 Clinical Case Study: Cervical Spine,https://clinicaltrials.gov/study/NCT03077204,,COMPLETED,"The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).",YES,Degenerative Disc Disease|Trauma (Including Fractures)|Spondylolisthesis,BIOLOGICAL: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).|DEVICE: Aviator Anterior Cervical Plating System,"Radiological Assessment : Fusion Status, This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say ""Yes"". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 ""yes""., Post-op 1 year|Arthrodesis Rates, Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis., Post-op 1 year","Revision Rates (if Any), As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery, Post-op 2~4 weeks|Revision Rates (if Any), As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery, Post-op 3 months|Revision Rates (if Any), As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery, Post-op 6 months|Revision Rates (if Any), As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery, Post-op 1 year|VAS, Patient reported VAS will be collected at different time intervals. The revision rate was described as the number of patients who had to undergo revision post index surgery. VAS: 0-10 (0=better, 10=worst), Pre-op|VAS, Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst), Post-op 2 ~ 4 weeks|VAS, Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst), Post-op 3 months|VAS, Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst), Post-op 6 months|VAS, Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst), Post-op 1 year|NDI, Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst), Pre-op|NDI, Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst), Post-op 2~4 weeks|NDI, Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst), Post-op 3 months|NDI, Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst), Post-op 6 months|NDI, Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst), Post-op 1 year|Arthrodesis Rates, Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis., Pre-op|Arthrodesis Rates, Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis., Post-op 2~4 weeks|Arthrodesis Rates, Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis., Post-op 3 months|Arthrodesis Rates, Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis., Post-op 6 months",,Seton Healthcare Family,,ALL,"ADULT, OLDER_ADULT",PHASE4,20,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,CR-16-109,2017-04-06,2020-01-30,2020-01-30,2017-03-10,2022-01-14,2022-01-14,"Seton Spine and Scoliosis Center, Austin, Texas, 78731, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/04/NCT03077204/Prot_SAP_001.pdf"
NCT04007094,Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery,https://clinicaltrials.gov/study/NCT04007094,,TERMINATED,"This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix. All subjects will be followed out to 24 months for final assessment.",YES,Degenerative Disc Disease|Spinal Stenosis|Spondylosis|Spondylolisthesis,OTHER: ViviGen Cellular Bone Matrix,"The Number of Surgical Levels With Successful Lumbar Fusion, Extent of fusion using the Lenke classification. Radiographic success defined as grade A, partial success grade B and radiographic failure as grades C and D., 12 months prospective from surgery","Number of Participants With or Without Changes in Visual Analog Scale Pain Scores, The visual analog scale will be used to rate leg and back pain scores from 0-10, with 10 being considered the most painful., 12 months prospectively from surgery|Oswestry Disability Index (ODI) v2.1a, This survey will be used to assess how back pain affects patients' ability to function in everyday life. We will look to see if subjects' scores improve or worsen on the Oswestry Disability Index scale (ODI) which can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life., 12 months prospectively from surgery",,Ohio State University,DePuy Synthes,ALL,"ADULT, OLDER_ADULT",NA,21,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,2018H0253,2019-02-12,2022-01-21,2022-01-21,2019-07-05,2024-01-24,2024-01-24,"Ohio State University, Columbus, Ohio, 43201, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/94/NCT04007094/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/94/NCT04007094/ICF_001.pdf"
NCT02539394,Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion,https://clinicaltrials.gov/study/NCT02539394,,COMPLETED,The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.,YES,Cervical Disc Herniation|Cervical Degenerative Disc Disease|Cervical Spondylotic Myelopathy|Dysphagia|Osteoarthritis of Cervical Spine,DRUG: Methylprednisolone Acetate|OTHER: Hemostatic Matrix Kit,"Degree of Dysphagia Patients Experience (Burden), SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Eating Desire), SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Eating Duration), SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Food Selection), SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Communication), SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Fear Swallow), SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Social), SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Mental), SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Sleep), SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Degree of Dysphagia Patients Experience (Fatigue), SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best), Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months","Patient Reported Swallowing Difficulty Over 1 Year, The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.

Modified Eat-10 : Eat-10 questionnaire without questions 1 (""My swallowing problem has caused me to lose weight"") and 2 (""My swallowing problem interferes with my ability to go out for meals"") to be applicable during hospitalization.

Eat-10 interpretation: Score ranging from 0 to 40 (best-worst)

* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)
* each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response, Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Bazaz Dysphagia Score - Liquid, Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods., Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Bazaz Dysphagia Score - Solid, Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods., Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Neck Disability, Neck Disability Index (NDI) Range from 0 to 100 (best-worst), Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Pain Scores on the Visual Analog Scale - Neck Pain, Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst), Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain, Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst), Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain, Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst), Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months|Change in Pre-vertebral Soft Tissue Swelling Over 1 Year, We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected., Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months|Fusion Rate, 1. Flex-Ex X-rays
2. Bony bridging on a CT scan
3. Obvious bony remodeling on lateral X-ray, 12 Months|Adverse Event, Adverse Event (AE) following surgical treatment.

Adverse event were classified by severity based on the AO-ISSG criteria and treatment required:

Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.

AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications), 12 month",,"Hospital for Special Surgery, New York",,ALL,"ADULT, OLDER_ADULT",NA,128,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION",2014-145,2015-08,2020-11-12,2021-11-12,2015-09-03,2023-07-10,2023-07-10,,"Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/94/NCT02539394/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/94/NCT02539394/ICF_001.pdf"
NCT03514277,A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief,https://clinicaltrials.gov/study/NCT03514277,,TERMINATED,"The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.",YES,Low Back Pain|Lumbosacral Radiculopathy|Lumbar Disc Degeneration|Lumbar Disc Herniation|Stenosis|Spondylolisthesis|Spondylolysis|Deformity of Spine,DRUG: Exparel|DRUG: Bupivacaine,"Mean Postoperative Pain Score, Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain, last day of hospitalization, average of 3 days in hospital","Total Consumption of Opioids During Hospital Stay, All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids, last day of hospitalization, average of 3 days in hospital|Mean Time to Achieve Physical Therapy Discharge, Mean time to achieve physical therapy discharge criteria, last day of hospitalization, average of 3 days in hospital|Number of Participants With Opioid Related Adverse Events, Number of Participants with Opioid Related Adverse Events, last day of hospitalization, average of 3 days in hospital",,"Virtua Health, Inc.",,ALL,"ADULT, OLDER_ADULT",PHASE4,19,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE",VirtuaHealthExparel,2016-12-01,2019-12-31,2019-12-31,2018-05-02,2021-01-06,2021-01-06,"Virtua Memorial Hospital, Mount Holly, New Jersey, 08060, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/77/NCT03514277/Prot_SAP_000.pdf"
NCT03647501,Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages,https://clinicaltrials.gov/study/NCT03647501,,COMPLETED,"The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM poly-ether-ether-ketone cage.",YES,Lumbar Degenerative Disc Disease|Lumbar Spinal Stenosis|Lumbar Spondylolisthesis|Lumbar Spinal Deformity|Lumbar Spondylosis,DEVICE: Interbody cage (titanium)|DEVICE: Interbody cage (PEEK),"Interbody Radiographic Fusion Rate, Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months., 6 months post-operatively","Post-operative Timing of Fusion, Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year., 12 months post-operatively",,Ohio State University,"Nexxt Spine, LLC",ALL,"ADULT, OLDER_ADULT",NA,53,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT,2018H0008,2018-08-22,2022-03-16,2022-03-16,2018-08-27,2023-06-15,2023-06-15,"Shelby Miracle, Columbus, Ohio, 43210, United States","Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/01/NCT03647501/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/01/NCT03647501/ICF_001.pdf"