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.

Figures

Fig. 1

Radiographs of a 58-year-old male patient with initial treatment and subsequent plate failure at 2 months

Fig. 2

a,b Post-operative X-rays; c 2-week CT showing P15-BGS in the anterior cortical area

Fig. 3

a One month after operation; b 3 months after operation; c,d 15 months after operation following treatment with P15-BGS

Fig. 4

Histological section at 4 months showing a resorbing particle of P15-BGS surrounded by newly formed bone