Degenerative Lumbar Spine DiseasesNCT07868510
Kore Fiber PLF Study
A study testing Kore Fiber and Autologous bone graft in people with Degenerative Lumbar Spine Diseases and Lumbar Degenerative Disc Disease, run by Kolosis Bio, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis
- What is being tested?
- Kore Fiber and Autologous bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or planning pregnancy during the study period
- Member of a vulnerable population (e.g., prisoners, cognitively impaired, unable to consent)
- Body mass index (BMI) > 45 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Clinical Research Manager, 614-293-4876, aladdin.alqaisi@osumc.edu
Brian Park, MD
About this study
Official title: A Prospective, Randomized Controlled Trial of Kore Fiber® Versus Autograft in Posterolateral Lumbar Fusion (PLF)
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
- Being tested
- Kore Fiber, Autologous bone graft
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kore FiberBiological
An aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber
Autologous bone graftOther
Autograft bone
| Study group | Role | What they receive |
|---|---|---|
| Kore Fiber | Experimental | Kore fiber used standalone in instrumented posterolateral fusion per level at the randomized assigned side Receives: 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. Receives: Other: Autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative year 1
Secondary outcomes (3)
Distribution of fusion grades, assessed by Computed Tomography (CT) using the side-specific Modified Lenke classification of fusion grade
Measured: 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.
Measured: baseline, postoperative months 3, 6, and year 1
Incidence and characterization of serious adverse events (SAEs) attributed to graft materials
Measured: postoperative year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolosis Bio, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Tabbaa, PhD, Study director, Kolosis Bio, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868510
- Sponsor's protocol ID
- KOLOSIS-001
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of Kore Fiber® Versus Autograft in Posterolateral Lumbar Fusion (PLF)
- ClinicalTrials.gov ID
- NCT07868510
- Acronym / sponsor ID
- KOLOSIS-001
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kolosis Bio, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kore Fiber | Experimental | Biological: Kore FiberKore fiber used standalone in instrumented posterolateral fusion per level at the randomized assigned side |
| Autologous bone graft | Active comparator | Other: Autologous bone graftAutologous bone graft used in instrumented posterolateral fusion per level at the randomized assigned control side of the spine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kore FiberAn aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber | Biological | Kore Fiber |
| Autologous bone graftAutograft bone | Other | Autologous bone graft |
Primary outcome
Rate of successful fusion at 1 year post-operatively
Time frame: postoperative year 1
- Defined as the proportion of fusion sides achieving Grade A per the side-specific modified Lenke classification of fusion.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Tabbaa, PhD study director
Kolosis Bio, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kore Fiber and Autologous bone graft in people with Degenerative Lumbar Spine Diseases and Lumbar Degenerative Disc Disease, run by Kolosis Bio, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Manager (801-662-0040, clinicalaffairs@kolosis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful fusion at 1 year post-operatively (time frame: postoperative year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.