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.
Age ≥18 years
Is undergoing standard of care of one- to four-level instrumented posterolateral fusion between L1 and S1
Has failed 6 months or more of conservative, non-operative treatment
Able to provide informed consent
Prior lumbar fusion surgery at the index levels planned for study treatment
Minimally invasive/tubular surgery
History of osteoporosis, osteopenia, osteomalacia, or osteoporotic fracture that may compromise fusion outcomes
Active or recent malignancy (within 3 years), or current treatment with chemotherapy, radiation, immunosuppressive agents, or chronic steroids
Crossover
Kore Fiber
Biological/VaccineAn aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber
Autologous bone graft
Other interventionAutograft bone
Rate of successful fusion at 1 year post-operatively
\- Defined as the proportion of fusion sides achieving Grade A per the side-specific modified Lenke classification of fusion.
Distribution of fusion grades, assessed by CT using the side-specific Modified Lenke classification of fusion grade
Changes from baseline (CFB) in Numerical Rating Scales (NRSs) on back pain and leg pain
Incidence and characterization of serious adverse events (SAEs) attributed to graft materials
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
