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  • HP:0008419: Intervertebral disc degeneration
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    HP:0008419: Intervertebral disc degeneration

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

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (4)


    Name (Synonyms) Correlation
    drug405 Autologous Bone Graft Wiki 0.71
    drug2151 Local Bone Autograft Wiki 0.71
    drug3886 TGplPTH1-34 in fibrin Wiki 0.71
    Name (Synonyms) Correlation
    drug4261 ViviGen® Cellular Bone Matrix Wiki 0.71

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D055959 Intervertebral Disc Degeneration NIH 1.00
    D013168 Spondylolisthesis NIH 0.71
    D013130 Spinal Stenosis NIH 0.71
    Name (Synonyms) Correlation
    D011843 Radiculopathy NIH 0.71
    D013122 Spinal Diseases NIH 0.50

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0003302 Spondylolisthesis HPO 0.71

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 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
    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
    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

    The 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
    Conditions
    1. Degenerative Disc Disease
    2. Spinal Fusion
    Interventions
    1. Combination Product: TGplPTH1-34 in fibrin
    2. 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


    HPO

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

    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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