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).
Degenerative disc disease (DDD) is a common disorder of the lumbar spine. Clinically, DDD causes discogenic back pain and may cause related radicular, neuropathic, claudicatory, and referred pain. This is a prospective, randomized and non-randomized, controlled, single-blind and open-label, dose-finding, multi-center study which intends to demonstrate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft. The study will enroll 50 patients with Degenerative Disk Disease (DDD) requiring single-level interbody fusion along with posterolateral fusion (PLF) with posterior fixation who meet eligibility criteria and agree to participate in the study. Safety and efficacy of KUR-113 Bone Graft will be evaluated by analyzing all clinical as well as radiological endpoints and adverse events. This phase 2a study is not powered to detect non-inferiority. All patients will undergo clinical and radiological assessments at initial hospital discharge (on average 3 days post-surgery), 6 weeks, 3, 6, 12 and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.
University of California San Diego
La Jolla, California, United States
Justin Parker Neurological Institute
Boulder, Colorado, United States
Radiographic interbody fusion
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).
Time frame: Month 12 post-surgery
Composite Endpoint
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.
Time frame: Month 6 and Month 12 post-surgery
Radiographic interbody fusion
Determined by IREP using CT-scans
Time frame: Month 6 post-surgery
Radiographic posterolateral fusion
Determined by IREP using CT-scans
Time frame: Month 6 and Month 12 post-surgery
ODI
Change from baseline
Time frame: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Leg Pain
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.
Time frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Back Pain
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.
Time frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University-Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Kansas Spine and Specialty Hospital
Wichita, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Orthopedic Associates of Michigan
Grand Rapids, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Hospital for Special Surgery
New York, New York, United States
...and 5 more locations
Number of Secondary Interventions
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
Time frame: Up to Month 24 post-surgery