No phaseNot yet recruitingAge-related condition
Kore Fiber PLF RCT
A Prospective, Randomized Controlled Trial of Kore Fiber® Versus Autograft in Posterolateral Lumbar Fusion (PLF)
- Sponsor
- Kolosis Bio, LLC (Industry)
- Enrolment
- 75 planned
- Conditions
- Degenerative Lumbar Spine Diseases; Lumbar Degenerative Disc Disease; Lumbar Spinal Stenosis; Spondylolisthesis
- Interventions
- Kore Fiber; Autologous bone graft
- Ages
- adults, older adults
- Registry
- NCT07868510
Full record on ClinicalTrials.gov
From the registry
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF). Participants will receive Kore Fiber on one side of the spine and autograft on the opposite side according to randomized assignment. Fusion outcomes, pain outcomes, and safety will be assessed over 12 months.
Primary outcomes
- Rate of successful fusion at 1 year post-operatively
History
Primary completion expected
Expected to start
Registered