KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar… (NCT04294004) | Clinical Trial Compass
UnknownPhase 2
KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
United States50 participantsStarted 2020-08-27
Plain-language summary
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).
Who can participate
Age range25 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent by the patient.
✓. Male or female patient ≥ 25 up to and including 75 years old. Females of childbearing potential with a negative urine pregnancy test at Screening. Females of childbearing potential 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 with leg pain requiring up to 3 levels of laminectomy/decompression and a single-level fusion (L2 - S1). DDD is defined by the presence of one or more of the following:
✓. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
✓. osteophyte formation of facet joints or vertebral endplates,
✓. decreased disc height by \> 2 mm, but dependent upon the spinal level,
✓. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
✓. disc degeneration and/or herniation,
Exclusion criteria
✕. Patients with open epiphyseal plates.
✕. Patient requiring emergency spinal decompression or spinal fusion.
✕. Patients requiring multilevel fusion or expected to need secondary intervention within one year following surgery.