Status: Not yet recruiting
Kore Fiber PLF RCT
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.
Participants needed: 75
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Kolosis Bio, LLCUpdated: Oct 9, 2026Locations: 1
Eligibility criteria
Age ≥18 years [+4]
Prior lumbar fusion surgery at the index levels planned for study treatment [+8]