Name (Synonyms) | Correlation | |
---|---|---|
D055959 | Intervertebral Disc Degeneration NIH | 0.71 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0008419 | Intervertebral disc degeneration HPO | 0.71 |
There is one clinical trial.
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).
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-surgeryDescription: 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