Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial.

BACKGROUND: Open reduction and internal fixation is the treatment of choice for displaced intra-articular calcaneal fractures at many orthopaedic trauma centers. The purpose of this study was to determine whether open reduction and internal fixation of displaced intra-articular calcaneal fractures results in better general and disease-specific health outcomes at two years after the injury compared with those after nonoperative management.
METHODS: Patients at four trauma centers were randomized to operative or nonoperative care. A standard protocol, involving a lateral approach and rigid internal fixation, was used for operative care. Nonoperative treatment involved no attempt at closed reduction, and the patients were treated only with ice, elevation, and rest. All fractures were classified, and the quality of the reduction was measured. Validated outcome measures included the Short Form-36 (SF-36, a general health survey) and a visual analog scale (a disease-specific scale).
RESULTS: Between April 1991 and December 1997, 512 patients with a calcaneal fracture were treated. Of those patients, 424 with 471 displaced intra-articular calcaneal fractures were enrolled in the study. Three hundred and nine patients (73%) were followed and assessed for a minimum of two years and a maximum of eight years of follow-up. The outcomes after nonoperative treatment were not found to be different from those after operative treatment; the score on the SF-36 was 64.7 and 68.7, respectively (p = 0.13), and the score on the visual analog scale was 64.3 and 68.6, respectively (p = 0.12). However, the patients who were not receiving Workers' Compensation and were managed operatively had significantly higher satisfaction scores (p = 0.001). Women who were managed operatively scored significantly higher on the SF-36 than did women who were managed nonoperatively (p = 0.015). Patients who were not receiving Workers' Compensation and were younger (less than twenty-nine years old), had a moderately lower Böhler angle (0 degrees to 14 degrees ), a comminuted fracture, a light workload, or an anatomic reduction or a step-off of < or =2 mm after surgical reduction (p = 0.04) scored significantly higher on the scoring scales after surgery compared with those who were treated nonoperatively.
CONCLUSIONS: Without stratification of the groups, the functional results after nonoperative care of displaced intra-articular calcaneal fractures were equivalent to those after operative care. However, after unmasking the data by removal of the patients who were receiving Workers' Compensation, the outcomes were significantly better in some groups of surgically treated patients.

RCT Entities:   Population Interventions Outcomes