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Not Yet Recruiting NCT07868510

Kore Fiber PLF Study

Conditions: Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Kolosis Bio, LLC

Location: The Ohio State University Wexner Medical Center Columbus Ohio

Summary

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.

Eligibility Criteria

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 current treatment with chemotherapy, radiation, immunosuppressive agents, or chronic steroids 5. Active systemic infection or localized infection at the operative site 6. Cognitive, psychological, or neurological condition that may interfere with pain assessment or study compliance 7. Pregnant or planning pregnancy during the study period 8. Member of a vulnerable population (e.g., prisoners, cognitively impaired, unable to consent) 9. Body mass index (BMI) \> 45 kg/m²

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07868510). StuddyBuddy aggregates publicly available trial information.