An interventional study of Kore Fiber and Autologous bone graft in Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease and Lumbar Spinal Stenosis, sponsored by Kolosis Bio, LLC. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Kolosis Bio, LLC · Not applicable, Interventional, and Treatment
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.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 268 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →This is the only study on the registry with Kolosis Bio, LLC as lead sponsor.
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Exclusion Criteria:
Kore fiber used standalone in instrumented posterolateral fusion per level at the randomized assigned side
Biological: Kore Fiber
Autologous bone graft used in instrumented posterolateral fusion per level at the randomized assigned control side of the spine.
Other: Autologous bone graft
An aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber
Autograft 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.
Time frame: postoperative year 1
Distribution of fusion grades, assessed by Computed Tomography (CT) using the side-specific Modified Lenke classification of fusion grade
Time frame: postoperative year 1
Changes from baseline (CFB) in Numerical Rating Scale (NRS) scores on back pain and leg pain, where 0 = no pain and 10 = worst possible pain.
Time frame: baseline, postoperative months 3, 6, and year 1
Incidence and characterization of serious adverse events (SAEs) attributed to graft materials
Time frame: postoperative year 1
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →