Covid 19 Research using Clinical Trials (Home Page)
Report for D013122: Spinal Diseases NIH
(Synonyms: Spinal Di, Spinal Dis, Spinal Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1351 | Local Bone Autograft Wiki | 1.00 |
| drug2669 | ViviGen® Cellular Bone Matrix Wiki | 1.00 |
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013168 | Spondylolisthesis NIH | 1.00 |
| D013130 | Spinal Stenosis NIH | 1.00 |
| D011843 | Radiculopathy NIH | 1.00 |
| D055959 | Intervertebral Disc Degeneration NIH | 0.71 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003302 | Spondylolisthesis HPO | 1.00 |
| HP:0008419 | Intervertebral disc degeneration HPO | 0.71 |
There is one clinical trial.
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
HPO Nodes
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 postoperative