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Operative versus nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial
Agren P-H, Wretenberg P, Sayed-Noor AS
Journal of Bone and Joint Surgery -- American Volume 2013 Aug 7;95(15):1351-1357
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: We conducted a prospective, randomized, controlled multicenter trial to compare operative with nonoperative treatment of displaced intra-articular calcaneal fractures. METHODS: Eighty-two patients who presented to five trauma centers from 1994 to 1998 with an intra-articular calcaneal fracture with >= 2 mm of displacement (as verified by computed tomography) were randomized to operative or nonoperative treatment. Independent observers followed the two groups radiographically and clinically at one year and eight to twelve years. The primary outcome measures were a visual analog scale (VAS) for pain and function and the self-administrated Short Form (SF)-36 general health outcome questionnaire. The secondary outcome measures were residual pain evaluated with a VAS, the American Orthopaedic Foot and Ankle Society (AOFAS) scale, and the Olerud-Molander (OM) scale. RESULTS: Forty-two patients in the operative treatment group and forty in the nonoperative group were included. The two groups were comparable with respect to age, sex, and fracture types. Seventy-six patients were available for follow-up at one year and fifty-eight at eight to twelve years. The primary and secondary outcome measures did not differ significantly between the two treatment groups at one year of follow-up. At eight to twelve years of follow-up, there was a trend toward better scores on the patient-reported primary VAS score for pain and function (p = 0.07) and the physical component of the SF-36 (p = 0.06) in the operative group. The prevalence of radiographically evident posttraumatic subtalar arthritis was lower in the operative group (risk reduction 41%). CONCLUSIONS: Operative treatment was not superior in managing displaced intra-articular calcaneal fractures at one year of follow-up but appeared to have some benefits at eight to twelve years. Operative treatment was associated with a higher risk of complications but a reduced prevalence of posttraumatic arthritis evident on follow-up radiographs. LEVEL OF EVIDENCE: Therapeutic level II.

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