Covid 19 Research using Clinical Trials (Home Page)
HP:0008419: Intervertebral disc degenerationHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug298 | Autologous Bone Graft Wiki | 0.71 |
| drug2816 | TGplPTH1-34 in fibrin Wiki | 0.71 |
| drug1582 | Local Bone Autograft Wiki | 0.71 |
| drug3094 | ViviGen® Cellular Bone Matrix Wiki | 0.71 |
There are 2 clinical trials
Clinical Trials
1 Clinical Outcomes Associated With the Use of ViviGen® in Conjunction With Posterolateral Fusion for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.
NCT03733626 Lumbar Spondylolisthesis Degenerative Disc Disease Degenerative Spondylolisthesis Lumbar Radiculopathy Lumbar Spinal Stenosis Lumbar Disc Disease Combination Product: ViviGen® Cellular Bone Matrix Combination Product: Local Bone Autograft MeSH:Spinal Stenosis Spinal Diseases Intervertebral Disc Degeneration Spondylolisthesis Radiculopathy
HPO:Intervertebral disc degeneration Spondylolisthesis
Primary Outcomes
Description: Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Measure: Incidence of successful Lumbar Fusion measured radiographically Time: 12 months postoperative
Secondary Outcomes
Description: Equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months.
Measure: Visual Analog Scale for Pain Time: 12 months postoperative
Description: Equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Measure: Change in Oswestry Disability Index for Pain and Function Time: 12 months postoperative
Description: Equal to or greater than 15-point increase in patient reported outcomes as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
Measure: Change in Short Form Health Survey-36 for Quality of Life Time: 12 months postoperative
Description: Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Measure: Neurological Deficit per Lumbar Spine Neurological Exam Time: 12 months postoperative
Description: Count of participants with revision surgery by month 12
Measure: Count of participants with revision surgery by month 12 Time: 12 months postoperative
Description: Count of participants developing pseudoarthrosis by month 12
Measure: Count of participants developing pseudoarthrosis by month 12 Time: 12 months postoperative
2 A Prospective, Randomized, Controlled, Single-blind, Dose-finding, Multi-center, Parallel Group Study of Safety/Efficacy of KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
Primary Outcomes
Description: Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Measure: Incidence of successful Lumbar Fusion measured radiographically Time: 12 months postoperativeSecondary Outcomes
Description: Equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months.
Measure: Visual Analog Scale for Pain Time: 12 months postoperativeDescription: Equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Measure: Change in Oswestry Disability Index for Pain and Function Time: 12 months postoperativeDescription: Equal to or greater than 15-point increase in patient reported outcomes as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
Measure: Change in Short Form Health Survey-36 for Quality of Life Time: 12 months postoperativeDescription: Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Measure: Neurological Deficit per Lumbar Spine Neurological Exam Time: 12 months postoperativeDescription: Count of participants with revision surgery by month 12
Measure: Count of participants with revision surgery by month 12 Time: 12 months postoperativeDescription: Count of participants developing pseudoarthrosis by month 12
Measure: Count of participants developing pseudoarthrosis by month 12 Time: 12 months postoperativeThe purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).
NCT04294004 Degenerative Disc Disease Spinal Fusion Combination Product: TGplPTH1-34 in fibrin Other: Autologous Bone Graft MeSH:Intervertebral Disc Degeneration
HPO:Intervertebral disc degeneration
Primary Outcomes
Description: Evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body on CT-scan as determined by an independent radiology expert panel (IREP).
Measure: Radiographic interbody fusion Time: Month 12 post-surgery
Secondary Outcomes
Description: Radiographic interbody fusion using CT-scans, functional outcome (decrease of 15 points or more on Oswestry Disability Index (ODI)) and no post-surgical intervention to aid fusion or replace any of the spinal implants.
Measure: Composite Endpoint Time: Month 6 and Month 12 post-surgery
Description: Determined by IREP using CT-scans
Measure: Radiographic interbody fusion Time: Month 6 post-surgery
Description: Determined by IREP using CT-scans
Measure: Radiographic posterolateral fusion Time: Month 6 and Month 12 post-surgery
Description: Change from baseline
Measure: ODI Time: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Description: Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measure: Leg Pain Time: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Description: Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measure: Back Pain Time: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Description: Revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or in any way removes part of the original implant configuration with or without replacement of the components
Measure: Number of Secondary Interventions Time: Up to Month 24 post-surgery
HPO Nodes
Primary Outcomes
Description: Evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body on CT-scan as determined by an independent radiology expert panel (IREP).
Measure: Radiographic interbody fusion Time: Month 12 post-surgerySecondary Outcomes
Description: Radiographic interbody fusion using CT-scans, functional outcome (decrease of 15 points or more on Oswestry Disability Index (ODI)) and no post-surgical intervention to aid fusion or replace any of the spinal implants.
Measure: Composite Endpoint Time: Month 6 and Month 12 post-surgeryDescription: Determined by IREP using CT-scans
Measure: Radiographic interbody fusion Time: Month 6 post-surgeryDescription: Determined by IREP using CT-scans
Measure: Radiographic posterolateral fusion Time: Month 6 and Month 12 post-surgeryDescription: Change from baseline
Measure: ODI Time: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgeryDescription: Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measure: Leg Pain Time: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgeryDescription: Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measure: Back Pain Time: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgeryDescription: Revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or in any way removes part of the original implant configuration with or without replacement of the components
Measure: Number of Secondary Interventions Time: Up to Month 24 post-surgery