Session X1I - Foot and Ankle


Sat., 10/22/05 Foot and Ankle, Paper #53, 3:00 pm

A Prospective Randomized Controlled Trial of a Bioresorbable Calcium Phosphate Paste (Alpha-BSM) in Displaced Intra-articular Calcaneal Fractures

Ian Le, MD; Richard E. Buckley, MD, FRCSC;
Ross K Leighton, MD, FRCSC (all authors a-DePuy, a Johnson and Johnson Company ); University of Calgary and Dalhousie University, Calgary, Alberta, Canada; Halifax, Nova Scotia, Canada

Purpose: This investigation was conducted to determine whether ORIF (open reduction and internal fixation) plus an injectable bioresorbable calcium phosphate paste (Alpha-BSM) is superior or inferior to ORIF alone in maintaining postoperative calcaneal height (Bohlers angle) and articular reduction in displaced intra-articular fractures of the calcaneus.

Methods: 44 patients with 48 closed displaced intra-articular calcaneal fractures (OTA 73-C1, C2, and C3) necessitating operative fixation provided informed consent. Patients were randomized 1:1 to receive ORIF and injection of Alpha-BSM or ORIF alone. All patients had a standardized ORIF through a lateral approach by two experienced trauma surgeons. The maintenance of postoperative Bohlers angle was measured at 6 weeks, 3 months, 6 months, and 1 year. Secondary outcome measures included the SF-36 and LEM scores at 6 months and 1 year.

Results: Five patients had inadequate follow-up, leaving 39 (41 fractures). 21 received ORIF and Alpha-BSM and 20 received ORIF alone. There was no statistical difference between the two groups with regard to age, sex, workers' compensation status, smoking, initial Bohlers angle, or type of fracture. There was no difference between the groups in the degree of collapse of Bohlers angle at 6 weeks and 3 months. However, at 6 months there was a statistically significant difference in mean collapse of ORIF and Alpha-BSM (5.6°) versus ORIF alone (10.6°) (P=0.03).

Conclusion: These results support the use of Alpha-BSM to prevent the loss of calcaneal height and maintain an anatomic calcaneal reduction.

Significance: This substance may assist trauma surgeons in the easy maintenance of a difficult reduction and prevent late collapse or loss of reduction in a very difficult fracture. Previous studies have questioned the use of autograft, allograft, or bone substitutes in this area.

If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.