A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF A BIORESORBABLE CALCIUM PHOSPHATE PASTE (_-BSM) IN DISPLACED INTRAARTICULAR CALCANEAL FRACTURES

Abstract

These results support the use of an injectable, in situ hardening calcium phosphate paste to prevent the early loss of calcaneal height and maintain a more anatomic calcaneal reduction.

The purpose of this prospective randomized controlled trial was to determine whether ORIF plus an injectable bioresorbable calcium phosphate paste (_-BSM) is superior or inferior to ORIF alone in the treatment of calcaneal bone voids encountered after operative treatment of displaced intraarticular fractures of the calcaneus.

Forty-four patients (forty-eight displaced intraarticular calcaneal fractures necessitating operative fixation) presenting to a Level One trauma center were enrolled into the study and randomized 1:1 to receive ORIF and injection of _-BSM or ORIF alone. All patients had a standardized ORIF thru a lateral approach by a single surgeon (R.B.).

The primary outcome measure was the maintenance of post- operative Bohler’s angle at six weeks, three months, and six months. Other outcome measures included the SF-36 and LEM (Lower Extremity Measure) Score at six months.

Five patients with seven calcaneal fractures were lost to follow up leaving thirty-nine patients with forty-one calcaneal fractures (85%) for analysis. Twenty-one were randomized into the ORIF and _-BSM group and twenty into the ORIF alone group. There was no statistical difference between the two groups with regard to age, sex, mechanism of injury, initial Bohler’s angle, or type of fracture.

There was no difference between the groups in the degree of collapse of Bohler’s angle at six weeks and three months when compared to initial post-operative values. However, at six months the mean collapse of the _-BSM and ORIF group was 5.6° and ORIF alone was 10.6°. This was statistically significant (p< 0.01).

Funding: Industry supported: DePuy, a Johnson & Johnson Company

Analysis and data collection performed independently.