Degenerative Disc DiseaseNCT03438747
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
A study testing P-15L Bone Graft and Local autologous bone in a TLIF with Instrumentation in people with Degenerative Disc Disease, run by CeraPedics, Inc at 34 sites in United States.
Trial summary
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- P-15L Bone Graft and Local autologous bone in a TLIF with Instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 34 sitesUnited States
- Study dates
- 24 Apr 2018to 28 Feb 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature adults between 22 and 80 years old (inclusive);
- Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;
- Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;
- Involved disc(s) between L2 and S1;
Who cannot join
- Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;
- Active malignancy;
- Nondiscogenic source of symptoms (e.g. tumor, etc.);
- Multiple level symptomatic degenerative disc disease where more than one level requires fusion;
- Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;
- More than one level to be fused
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
University of Michigan
Ann Arbor, Michigan, 48109
Austin Neurosurgeons
Austin, Texas, 78746
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
University Of Buffalo
Buffalo, New York, 14203
Indiana Spine Group
Carmel, Indiana, 46032
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
UConn Health
Farmington, Connecticut, 06030
Glendale Adventist Medical Center
Glendale, California, 91206
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
OrthoIndy
Indianapolis, Indiana, 46278
Keck School of Medicine USC
Los Angeles, California, 90033
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
The Orthopedic Center at Mount Sinai West
New York, New York, 10029
UC Irvine Medical Center
Orange, California, 92868
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Rothman Institute
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Canter
Pittsburgh, Pennsylvania, 15213
Texas Back Institute
Plano, Texas, 73509
UC Davis Spine Center
Sacramento, California, 95816
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Swedish Medical Center
Seattle, Washington, 98122
SUNY Upstate Medical Center
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33606
Florida Orthopaedic Institute
Tampa, Florida, 33637
Center for Spine and Orthopedics
Thornton, Colorado, 80229
Carle Foundation Hospital
Urbana, Illinois, 61801
Cedars-Sinai
West Hollywood, California, 90069
About this study
Official title: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.
- Conditions
- Degenerative Disc Disease
- Being tested
- P-15L Bone Graft, Local autologous bone in a TLIF with Instrumentation
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-15L Bone GraftDevice
The investigational group will be treated with P-15L in an instrumented TLIF
Local autologous bone in a TLIF with InstrumentationOther
The active control group will be treated local autologous bone in an instrumented TLIF
| Study group | Role | What they receive |
|---|---|---|
| P-15L Bone Graft | Experimental | The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF Receives: Device: P-15L Bone Graft |
| Local autologous bone | Active comparator | The active control group will be treated with local autologous bone in an instrumented TLIF Receives: Other: Local autologous bone in a TLIF with Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary surgical intervention
No index level secondary surgical intervention
Measured: 72 Months
Fusion
Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Measured: 72 Months
Oswestry Disability Index (ODI)
At least 15-point improvement in Oswestry Disability Index (ODI)
Measured: 72 Months
Neurological deficit
No new or worsening, persistent neurological deficit
Measured: 72 Months
No serious device-related adverse event
No serious device-related adverse event
Measured: 72 Months
Secondary outcomes (3)
Time to Fusion
The distribution of visits (month 6, 12, or 24) at which fusion is confirmed is the same for the investigational and control devices.
Measured: 24 months
VAS pain scores
Pain at back and pain at legs will be measured by a 100-point Visual Analog Scale (VAS)
Measured: 72 months
Physical Function and Mental Health Composite Scores
SF-12 and changes over time
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start24 Apr 2018
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeraPedics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438747
- Sponsor's protocol ID
- CP-1006
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2018
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Harrop JS, O'Toole JE, Steinmetz MP, Sasso RC, Chaput CD, Strenge KB, Maislin G, Mullin JP, Freeman TB, Guanciale A, Lantner H, Janssen ME, Schwartz DG, Small JM, Hsu WK, Arnold PM. P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success. Spine (Phila Pa 1976). 2026 Feb 15;51(4):238-247. doi: 10.1097/BRS.0000000000005579. Epub 2025 Dec 19.
PubMed 41307132Harrop JS, Steinmetz MP, O'Toole JE, Chaput CD, Sasso RC, Strenge KB, Maislin G, Mullin JP, Freeman TB, Guanciale A, Lantner H, Janssen ME, Schwartz DG, Small JM, Hsu WK, Arnold PM. P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study. Spine (Phila Pa 1976). 2026 Feb 15;51(4):229-237. doi: 10.1097/BRS.0000000000005580. Epub 2025 Dec 19.
PubMed 41307110
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
- ClinicalTrials.gov ID
- NCT03438747
- Acronym / sponsor ID
- CP-1006
- Conditions
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (actual)
- Lead sponsor
- CeraPedics, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Feb 2018 (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.
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-15L Bone Graft | Experimental | Device: P-15L Bone GraftThe investigational group will be treated with P-15L Bone Graft in an instrumented TLIF |
| Local autologous bone | Active comparator | Other: Local autologous bone in a TLIF with InstrumentationThe active control group will be treated with local autologous bone in an instrumented TLIF |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature adults between 22 and 80 years old (inclusive);
- Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;
- Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;
- Involved disc(s) between L2 and S1;
Key exclusion criteria (6 listed)
- Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;
- Active malignancy;
- Nondiscogenic source of symptoms (e.g. tumor, etc.);
- Multiple level symptomatic degenerative disc disease where more than one level requires fusion;
- Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;
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 |
|---|---|---|
| P-15L Bone GraftThe investigational group will be treated with P-15L in an instrumented TLIF | Device | P-15L Bone Graft |
| Local autologous bone in a TLIF with InstrumentationThe active control group will be treated local autologous bone in an instrumented TLIF | Other | Local autologous bone |
Primary outcome
Secondary surgical intervention
Time frame: 72 Months
No index level secondary surgical intervention
Fusion
Time frame: 72 Months
Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Oswestry Disability Index (ODI)
Time frame: 72 Months
At least 15-point improvement in Oswestry Disability Index (ODI)
Neurological deficit
Time frame: 72 Months
No new or worsening, persistent neurological deficit
No serious device-related adverse event
Time frame: 72 Months
No serious device-related adverse event
3 secondary outcomes
Time to Fusion
Time frame: 24 months
VAS pain scores
Time frame: 72 months
Physical Function and Mental Health Composite Scores
Time frame: 72 months
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 6 Oct 2025.
- Derived from this study: PubMed 41307132Harrop JS, O'Toole JE, Steinmetz MP, Sasso RC, Chaput CD, Strenge KB, Maislin G, Mullin JP, Freeman TB, Guanciale A, Lantner H, Janssen ME, Schwartz DG, Small JM, Hsu WK, Arnold PM. P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success. Spine (Phila Pa 1976). 2026 Feb 15;51(4):238-247. doi: 10.1097/BRS.0000000000005579. Epub 2025 Dec 19.
- Derived from this study: PubMed 41307110Harrop JS, Steinmetz MP, O'Toole JE, Chaput CD, Sasso RC, Strenge KB, Maislin G, Mullin JP, Freeman TB, Guanciale A, Lantner H, Janssen ME, Schwartz DG, Small JM, Hsu WK, Arnold PM. P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study. Spine (Phila Pa 1976). 2026 Feb 15;51(4):229-237. doi: 10.1097/BRS.0000000000005580. Epub 2025 Dec 19.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-15L Bone Graft and Local autologous bone in a TLIF with Instrumentation in people with Degenerative Disc Disease, run by CeraPedics, Inc at 34 sites 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary surgical intervention (time frame: 72 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438747, which also lists 2 linked publications.
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 6 Oct 2025.