KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion (STRUCTURE)

  • End date
    Sep 30, 2024
  • participants needed
  • sponsor
    Kuros Biosurgery AG
Updated on 20 April 2022
conservative management
bone graft
bed rest
disc disease


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, 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.

Condition Degenerative Disc Disease, Spinal Fusion
Treatment Autologous bone graft, TGplPTH1-34 in fibrin
Clinical Study IdentifierNCT04294004
SponsorKuros Biosurgery AG
Last Modified on20 April 2022


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