KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Spinal Fusion
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Due to the different technical procedures between the control and the intervention arms (KUR-113 Bone Graft versus local autograft), investigators cannot be blinded to the treatment. However, all patients will remain blinded for the duration of their participation in the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 75 years
- Gender
- Both males and females
Description
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, controlled, single-blind, dose-finding, multi-center study which int...
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, controlled, single-blind, 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.
Tracking Information
- NCT #
- NCT04294004
- Collaborators
- Factory CRO
- Kuros BioSciences B.V.
- Investigators
- Principal Investigator: John Chi, MD Brigham and Women's Hospital
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