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TGplPTH1-34 in fibrinWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug298 Autologous Bone Graft Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D055959 Intervertebral Disc Degeneration NIH 0.71

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0008419 Intervertebral disc degeneration HPO 0.71

There is one clinical trial.

Clinical Trials

1 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 Degenerative Disc Disease Spinal Fusion Combination Product: TGplPTH1-34 in fibrin 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

Related HPO nodes (Using clinical trials)

HP:0008419: Intervertebral disc degeneration
Genes 4
LMNA SMAD3 SMAD3 HGD
Protein Mutations 0
SNP 0