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D011843: Radiculopathy

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2151 Local Bone Autograft Wiki 1.00
drug4261 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
D013122 Spinal Diseases NIH 0.71
Name (Synonyms) Correlation
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

Clinical Trials

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There is one clinical trial.


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
Conditions
  1. Lumbar Spondylolisthesis
  2. Degenerative Disc Disease
  3. Degenerative Spondylolisthesis
  4. Lumbar Radiculopathy
  5. Lumbar Spinal Stenosis
  6. Lumbar Disc Disease
Interventions
  1. Combination Product: ViviGen® Cellular Bone Matrix
  2. 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


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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