BACKGROUND: Nonoperative management of complete acromioclavicular (AC) joint dislocation has yielded reasonable results, although patients may report dissatisfaction with the outcome. The purpose of this prospective, randomized, controlled trial was to compare patient outcome following nonoperative care versus operative treatment with open reduction and tunneled suspension device (ORTSD) fixation for acute, type-III or IV disruptions of the AC joint. METHODS:Sixty patients aged 16 to 35 years with an acute type-III or IV disruption of the AC joint were randomized to receive ORTSD fixation or nonoperative treatment, following a power analysis to determine sample size. Functional outcomes were assessed with use of the Disabilities of the Arm, Shoulder and Hand (DASH) as the primary outcome measure and the Oxford Shoulder Scores (OSS) and Short Form (SF-12) as secondary outcome measures at 6 weeks, 3 months, 6 months, and 1 year after treatment. Reduction was evaluated with use of radiographs. Any complications were noted at each assessment. The economic implication of each treatment was evaluated. RESULTS: ORTSD and nonoperative groups were similar with regard to demographics at baseline. The mean degree of radiographic displacement was significantly less in patients following ORTSD fixation (1.75 mm) compared with patients who received nonoperative treatment (10.61 mm, p < 0.0001). At 1 year postoperatively, the mean DASH score was 4.67 in the nonoperative treatment group and 5.63 in the ORTSD group, and the mean OSS was 45.72 and 45.63, respectively. Patients managed with ORTSD fixation had inferior DASH scores at 6 weeks (p < 0.01). There were 5 patients who experienced failed nonoperative treatment and subsequently underwent a surgical procedure. ORTSD fixation (£3,359.73) was associated with significantly higher costs than nonoperative treatment (£796.22, p < 0.0001). CONCLUSIONS:ORTSD fixation confers no functional benefit over nonoperative treatment at 1 year following type-III or IV disruptions of the AC joint. Although patients managed nonoperatively generally recovered faster, a substantial group of patients remained dissatisfied following nonoperative treatment and required delayed surgical reconstruction. We were unable to identify any demographic or injury-related factors that predicted a poorer outcome in these patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND: Nonoperative management of complete acromioclavicular (AC) joint dislocation has yielded reasonable results, although patients may report dissatisfaction with the outcome. The purpose of this prospective, randomized, controlled trial was to compare patient outcome following nonoperative care versus operative treatment with open reduction and tunneled suspension device (ORTSD) fixation for acute, type-III or IV disruptions of the AC joint. METHODS: Sixty patients aged 16 to 35 years with an acute type-III or IV disruption of the AC joint were randomized to receive ORTSD fixation or nonoperative treatment, following a power analysis to determine sample size. Functional outcomes were assessed with use of the Disabilities of the Arm, Shoulder and Hand (DASH) as the primary outcome measure and the Oxford Shoulder Scores (OSS) and Short Form (SF-12) as secondary outcome measures at 6 weeks, 3 months, 6 months, and 1 year after treatment. Reduction was evaluated with use of radiographs. Any complications were noted at each assessment. The economic implication of each treatment was evaluated. RESULTS: ORTSD and nonoperative groups were similar with regard to demographics at baseline. The mean degree of radiographic displacement was significantly less in patients following ORTSD fixation (1.75 mm) compared with patients who received nonoperative treatment (10.61 mm, p < 0.0001). At 1 year postoperatively, the mean DASH score was 4.67 in the nonoperative treatment group and 5.63 in the ORTSD group, and the mean OSS was 45.72 and 45.63, respectively. Patients managed with ORTSD fixation had inferior DASH scores at 6 weeks (p < 0.01). There were 5 patients who experienced failed nonoperative treatment and subsequently underwent a surgical procedure. ORTSD fixation (£3,359.73) was associated with significantly higher costs than nonoperative treatment (£796.22, p < 0.0001). CONCLUSIONS: ORTSD fixation confers no functional benefit over nonoperative treatment at 1 year following type-III or IV disruptions of the AC joint. Although patients managed nonoperatively generally recovered faster, a substantial group of patients remained dissatisfied following nonoperative treatment and required delayed surgical reconstruction. We were unable to identify any demographic or injury-related factors that predicted a poorer outcome in these patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.