Name (Synonyms) | Correlation | |
---|---|---|
drug1582 | Local Bone Autograft Wiki | 1.00 |
drug3094 | ViviGen® Cellular Bone Matrix Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D013168 | Spondylolisthesis NIH | 1.00 |
D011843 | Radiculopathy NIH | 1.00 |
D013122 | Spinal Diseases NIH | 0.71 |
D055959 | Intervertebral Disc Degeneration NIH | 0.71 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0003302 | Spondylolisthesis HPO | 1.00 |
HP:0008419 | Intervertebral disc degeneration HPO | 0.71 |
There is one clinical trial.
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.
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 postoperativeDescription: 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