General Health Status After Nonoperative Versus Operative Treatment for Acute, Complete Acromioclavicular Joint Dislocation: Results of a Multicenter Randomized Clinical Trial.

OBJECTIVE: To assess the general health status of patients after nonoperative (Non-op) versus operative (OP) treatment for acromioclavicular (AC) joint dislocations.
DESIGN: Multicenter randomized controlled clinical trial conducted in 11 Canadian trauma centers. A total of 83 patients with acute (≤28 days old), complete (Rockwood grades III, IV, or V) dislocations of the AC joint were included in this study. INTERVENTION: Participants were randomized to Non-op treatment or OP treatment with hook plate fixation. MAIN OUTCOME MEASURES: Physical and mental health were evaluated using the Short Form-36 version 2 survey at baseline, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
RESULTS: In the Non-op group, 33 patients had grade III injuries, 3 patients had grade IV injuries, 5 patients had grade V injuries, and the injury grade was unknown for 2 patients. In the OP group, 37 patients had grade III injuries and 3 patients had grade V injuries (no difference in Type IV and V Non-op vs. OP, P = 0.12). Fifty-eight percent of patients in the Non-op group and 63% of patients in the OP group completed the 2-year follow-up. The Non-op group had better physical health scores than the OP group at 3 months after treatment (52.13 vs. 45.75, P < 0.001). There were no significant differences between the physical health scores of the 2 groups at any other point (6 weeks, 45.81 vs. 41.21, P = 0.03; 6 months, 54.50 vs. 51.61, P = 0.02; 1 year, 55.10 vs. 53.96, P = 0.37; 2 years, 55.24 vs. 57.13, P = 0.17). Mental health scores were similar between the Non-op and OP groups at each follow-up interval (6 weeks, 49.29 vs. 51.27, P = 0.49; 3 months, 52.24 vs. 55.84, P = 0.13; 6 months, 54.89 vs. 55.05, P = 0.93; 1 year, 55.35 vs. 56.72, P = 0.35; 2 years, 56.41 vs. 55.43, P = 0.56). In both treatment groups, the preinjury physical and mental health scores were better than published population norms before declining to a level equal to or below the norm after dislocation. Physical health recovered to a level above the norm at 6 months in the Non-op group and 2 years in the OP group. Mental health recovered at 3 months in the OP group and 6 months in the Non-op group.
CONCLUSIONS: Hook plate fixation does not lead to improved general health status compared with Non-op treatment. Presently, there is no definitive evidence that hook plate fixation is superior to Non-op treatment for acute complete AC joint dislocations. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

RCT Entities:   Population Interventions Outcomes