COVID-19 (Coronavirus)

STRUCTURE Study

Condition: Degenerative disc disease

Eligibility

Key Inclusion Criteria:

  • 25-75 years old (Females of childbearing potential must not be pregnant and must agree to use acceptable contraception for at least 12 months after surgery and investigational product placement.)
  • Patients with degenerative disc disease with up to grade 1 spondylolisthesis and leg pain requiring up to 3 levels of laminectomy/decompression and single-level fusion
  • Patients with an Oswestry Disability Index score ≥35

Key Exclusion Criteria:

  • Patients with open epiphyseal plates (layer of cartilage)
  • Requiring emergency spinal decompression or spinal fusion
  • Requiring multilevel fusion or expected to need secondary intervention within one year following surgery

Full Study Name

A Prospective, Randomized, Controlled, Single-Blind, Dose-Finding, Multicenter, Parallel Group Study of the Safety and Efficacy of KUR-113 Bone Graft (TGplPTH1-34 in Fibrin) Versus Local Autograft for the Treatment of Patients Undergoing Single-Level Transforaminal Lumbar Interbody Fusion (The STRUCTURE Study) (IRB no. 0000847)

Summary

This study focuses on individuals who have been diagnosed with degenerative disc disease and require surgery to prevent the damaged disc from moving (which would decrease associated pain). During this type of surgery, the damaged disc is removed, and the vertebras are fused together by inserting a device with a bone graft to help stabilize the spine during the healing process (a procedure called spinal fusion).
 
The purpose of this study is to examine the safety and effectiveness of an investigational drug called KUR-113 Bone Graft (compared to a local autograft) as a possible treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion. Researchers aim to determine how well the drug works, which dose is most effective, and how safe it is compared to standard surgical treatment using a local graft.

Principal Investigator
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