P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: STUDY DESIGN: Prospective, multicenter, single-blind, randomized, controlled pivotal study. OBJECTIVE: To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF). SUMMARY OF BACKGROUND DATA: P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation. MATERIALS AND METHODS: Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs). RESULTS: A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups. CONCLUSION: P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF. LEVEL OF EVIDENCE: Level I.
Source: Spine
Institutions: Thomas Jefferson University, Rush University Medical Center, Cleveland Clinic, Indiana Spine Group, Indiana University School of Medicine, Indiana University, The University of Texas at San Antonio Health Science Center, University at Buffalo, State University of New York, University of South Florida, University of Cincinnati, Saint Francis Hospital & Medical Center, Indiana Orthopaedic Hospital, Florida Orthopaedic Institute, Northwestern University, Loyola University Chicago
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4416745393