OBJECTIVE: To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. DESIGN: Prospective, randomized. SETTING: Multicenter. PATIENTS/PARTICIPANTS: Eight-three patients with acute (<28 days from the time of injury) complete (grade III, IV, and V) dislocations of the AC joint. INTERVENTION: Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). MAIN OUTCOME MEASUREMENTS: Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. RESULTS: There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P < 0.05). CONCLUSIONS: Although hook plate fixation resulted in superior radiographic alignment, it was not clinically superior to nonoperative treatment of acute complete dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate improves short-term outcome for complete AC joint dislocations.
RCT Entities:
OBJECTIVE: To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. DESIGN: Prospective, randomized. SETTING: Multicenter. PATIENTS/PARTICIPANTS: Eight-three patients with acute (<28 days from the time of injury) complete (grade III, IV, and V) dislocations of the AC joint. INTERVENTION: Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). MAIN OUTCOME MEASUREMENTS: Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. RESULTS: There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P < 0.05). CONCLUSIONS: Although hook plate fixation resulted in superior radiographic alignment, it was not clinically superior to nonoperative treatment of acute complete dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate improves short-term outcome for complete AC joint dislocations.