P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
1 other identifier
interventional
290
1 country
34
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
October 6, 2025
October 1, 2025
9.9 years
February 13, 2018
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Secondary surgical intervention
No index level secondary surgical intervention
72 Months
Fusion
Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
72 Months
Oswestry Disability Index (ODI)
At least 15-point improvement in Oswestry Disability Index (ODI)
72 Months
Neurological deficit
No new or worsening, persistent neurological deficit
72 Months
No serious device-related adverse event
No serious device-related adverse event
72 Months
Secondary Outcomes (3)
Time to Fusion
24 months
VAS pain scores
72 months
Physical Function and Mental Health Composite Scores
72 months
Study Arms (2)
P-15L Bone Graft
EXPERIMENTALThe investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
Local autologous bone
ACTIVE COMPARATORThe active control group will be treated with local autologous bone in an instrumented TLIF
Interventions
The investigational group will be treated with P-15L in an instrumented TLIF
The active control group will be treated local autologous bone in an instrumented TLIF
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CeraPedics, Inclead
Study Sites (34)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Keck School of Medicine USC
Los Angeles, California, 90033, United States
UC Irvine Medical Center
Orange, California, 92868, United States
UC Davis Spine Center
Sacramento, California, 95816, United States
Cedars-Sinai
West Hollywood, California, 90069, United States
Center for Spine and Orthopedics
Thornton, Colorado, 80229, United States
UConn Health
Farmington, Connecticut, 06030, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
University of South Florida
Tampa, Florida, 33606, United States
Florida Orthopaedic Institute
Tampa, Florida, 33637, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
OrthoIndy
Indianapolis, Indiana, 46278, United States
Norton Leatherman Spine Center
Louisville, Kentucky, 40202, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University Of Buffalo
Buffalo, New York, 14203, United States
The Orthopedic Center at Mount Sinai West
New York, New York, 10029, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Canter
Pittsburgh, Pennsylvania, 15213, United States
Austin Neurosurgeons
Austin, Texas, 78746, United States
Texas Back Institute
Plano, Texas, 73509, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (2)
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.
PMID: 41307132DERIVEDHarrop 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.
PMID: 41307110DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2018
First Posted
February 20, 2018
Study Start
April 24, 2018
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
October 6, 2025
Record last verified: 2025-10