Kore Fiber PLF RCT

NCT07868510 | Not Yet Recruiting

• 1 other identifier: KOLOSIS-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Lumbar Spine Diseases; Lumbar Degenerative Disc Disease; Lumbar Spinal Stenosis; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative year 1

Secondary Outcomes (3)

• Distribution of fusion grades, assessed by CT using the side-specific Modified Lenke classification of fusion grade

  postoperative year 1

• Changes from baseline (CFB) in Numerical Rating Scales (NRSs) on back pain and leg pain

  baseline, postoperative months 3, 6, and year 1

• Incidence and characterization of serious adverse events (SAEs) attributed to graft materials

  postoperative year 1

Study Arms (2)

Kore Fiber

EXPERIMENTAL

Kore fiber used standalone in instrumented posterolateral fusion per level at the randomized assigned side

Biological: Kore Fiber

Autologous bone graft

ACTIVE COMPARATOR

Autologous bone graft used in instrumented posterolateral fusion per level at the randomized assigned control side of the spine.

Other: Autologous bone graft

Interventions

Kore Fiber BIOLOGICAL

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

Kore Fiber

Autologous bone graft OTHER

Autograft bone

Autologous bone graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Agree to comply with study protocol

You may not qualify if:

• 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
• Active systemic infection or localized infection at the operative site
• Cognitive, psychological, or neurological condition that may interfere with pain assessment or study compliance
• Pregnant or planning pregnancy during the study period
• Member of a vulnerable population (e.g., prisoners, cognitively impaired, unable to consent)
• BMI \> 45

Sponsors & Collaborators

• Kolosis Bio, LLC: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Suzanne Tabbaa, PhD

  Kolosis Bio, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Study Manager

CONTACT

440-242-9659; clinicalaffairs@kolosis.com

Suzanne Tabbaa, PhD

CONTACT

440-242-9659; stabbaa@kolosis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is masked to side assignment
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an intra-patient controlled study. Every participant receives both interventions simultaneously. Randomization determines which product is applied to the left side versus the right side of the spine.

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)