title: P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial.
abstract: Treatment of non-unions and delayed unions often requires osteogenic material. Recently, a biomimetic bone matrix that simulates the cellular environment of hard tissue, identified as P-15, was introduced to the orthopaedic community. A total of 22 patients with mal-union or delayed union fractures was treated from June 2000 to October 2003 with P15- bone graft substitute (P15-BGS) in the site of fracture and mostly with internal fixation. Patients were examined by independent radiographic analysis. Assessment criteria included time elapsed until bone bridging and time to full consolidation. In addition, histological assessment of the callus was done at the time of recovery of metal implants in five patients. Full consolidation was achieved in 90% (20 out of 22) of the patients treated with P15-BGS. The average time for full consolidation was 4.2 months. Histological assessment of the fracture callus in five of the patients confirmed the positive clinical and radiographic results. P15-BGS appears to offer a safe, economical and clinically useful alternative to autograft in the repair of ununited fractures. These results compare favourably with those in the published literature as an alternative to autograft.
authors.affiliation: Department of Surgery, University of Valencia, El Bachiller 17, 46010, Valencia, Spain. francisco.gomar@uv.es
authors.forename: Francisco
authors.initials: F
authors.lastname: Gomar
authors.forename: Rafael
authors.initials: R
authors.lastname: Orozco
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Villar
authors.forename: Federico
authors.initials: F
authors.lastname: Arrizabalaga
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D001857:Bone Matrix / Q000637:transplantation*; D016025:Bone Transplantation / Q000379:methods*; D002146:Bony Callus / Q000473:pathology; D003094:Collagen / Q000627:therapeutic use*; D005260:Female; D005593:Fracture Fixation, Internal / Q000379:methods*; D017102:Fracture Healing; D005599:Fractures, Ununited / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016348:Osseointegration / Q000187:drug effects; D010446:Peptide Fragments / Q000627:therapeutic use*; D010865:Pilot Projects; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D010446:Peptide Fragments; C407062:cell-binding peptide P-15; D003094:Collagen