P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: STUDY DESIGN: Prospective, multicenter, single-blind, randomized, and controlled pivotal study. OBJECTIVE: Compare time-to-fusion in patients treated with P-15L (PearlMatrix TM P-15 peptide enhanced bone graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline. SUMMARY OF BACKGROUND DATA: P-15L, an FDA-designated breakthrough device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation. METHODS: Patients (22-80 y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared with the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12). RESULTS: The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least one risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational group than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs. 26.9%, respectively), 12 months (68.8% vs. 41.5%, respectively), and 24 months (81.1% vs. 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47-2.38; P < 0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months. CONCLUSION: P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months. LEVEL OF EVIDENCE: Level I.
Source: Spine
Institutions: Thomas Jefferson University, Cleveland Clinic, Rush University Medical Center, The University of Texas at San Antonio Health Science Center, Indiana Spine Group, Indiana University School of Medicine, Indiana University, 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: W4416735859