Kolosis Bio, LLC
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.
Inclusion Criteria: 1. Age ≥18 years 2. Is undergoing standard of care of one- to four-level instrumented posterolateral fusion between L1 and S1 3. Has failed 6 months or more of conservative, non-operative treatment 4. Able to provide informed consent 5. Agree to comply with study protocol Exclusion Criteria: 1. Prior lumbar fusion surgery at the index levels planned for study treatment 2. Minimally invasive/tubular surgery 3. History of osteoporosis, osteopenia, osteomalacia, or osteoporotic fracture that may compromise fusion outcomes 4. Active or recent malignancy (within 3 years), or…
An aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber
Autograft bone
Arctuva estimate
Verify or correct the compensation shown for this listing.