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Clinical Trials in the USA / NCT07868510
Starting soon Not applicable

Kore Fiber PLF Study

NCT07868510 · tracked via the Priya Life Science USA tracker
Sponsor
Kolosis Bio, LLC
Phase
Not applicable
Started
2026-11
Last updated
2026-10-16

Condition(s) studied

Degenerative Lumbar Spine DiseasesLumbar Degenerative Disc DiseaseLumbar Spinal StenosisSpondylolisthesis

Investigational drug(s) / intervention(s)

Kore FiberAutologous bone graft

Kore Fiber: An aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber

Autologous bone graft: Autograft bone

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of successful fusion at 1 year post-operatively — postoperative year 1
    \- Defined as the proportion of fusion sides achieving Grade A per the side-specific modified Lenke classification of fusion.

Trial sites (1)

FacilityCityRegionStatus
The Ohio State University Wexner Medical Center Columbus Ohio

Other trials for the same condition

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device Recruiting
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study Recruiting
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE) Active, not recruiting
Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft. Active, not recruiting
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07868510 on ClinicalTrials.gov ↗ ← All trials in the USA