Sat., 10/6/12 Upper Extremity Injuries, PAPER #91, 11:30 am OTA-2012
Δ Operative Versus Nonoperative Treatment of Acute Dislocations of the Acromioclavicular Joint: Results of a Multicenter Randomized, Prospective Clinical Trial
Michael D. McKee, MD; Stéphane Pelet, MD, PhD, FRCSC; Milena R. Vicente, RN, CCRP;
The Canadian Orthopaedic Trauma Society (COTS) Group;
St. Michael’s Hospital, Toronto, Ontario, Canada
Purpose: The optimal treatment for acute dislocation of the acromioclavicular (AC) joint remains unclear. Both surgical repair and nonoperative treatment have been advocated, but prior randomized trials did not reveal any significant differences between groups. However, these studies used inferior surgical techniques and surgeon-based or radiographic outcome measures. We sought to perform a randomized clinical trial of operative versus nonoperative treatment of acute AC joint dislocations using modern surgical fixation and patient-based outcome measures.
Methods: We performed a prospective, multicenter, randomized clinical trial comparing operative repair with hook plate fixation versus nonoperative treatment for acute (<3 weeks old) complete (grades III, IV, V) dislocations of the AC joint. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year postinjury. Assessment also included a complete clinical assessment, the Constant score, the Short Form-36 score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months.
Results: 83 patients were randomized (operative repair 40, nonoperative treatment 43). There were no demographic differences between the two groups (operative: male/female 36/4, nonoperative 42/1, P = 0.279; mean age operative group 38.7 years, nonoperative group 37.3 years, P = 0.778. The mechanisms of injury were similar between the two groups. DASH scores (a disability score—lower score is better) were significantly better in the nonoperative group at 6 weeks (operative 46, nonoperative 31, P = 0.007), and 3 months (operative 29, nonoperative 16, P = 0.01). There were no significant differences between the groups at 6 months (operative 14, nonoperative 12, P = 0.422), 1 year (operative 10, nonoperative 9, P = 0.997), or 2 years (operative 4, nonoperative 6, P = 0.492) postinjury. Similar values were seen for Constant scores at 6 weeks (operative 51, nonoperative 75, p <0.0001), 3 months (operative 69, nonoperative 85, P = 0.001), 6 months (operative 80, nonoperative 92, P = 0.001), 1 year (operative 91, nonoperative 91, P = 0.830) and 2 years (operative 93, nonoperative 89, P = 0.352). There were four major complications in the hook plate group (acromial erosion, 2; plate failure, 2). Radiographic outcomes and joint reduction were significantly better in the operative group.
Discussion: Hook plate fixation with presently available implants is not superior to nonoperative treatment for the 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, mean Constant score >90) at 2 years. Although joint reduction is reliably restored with hook plate fixation, there is no clear evidence that this operative treatment improves short-term outcome for complete AC joint dislocations. Further research and long-term follow-up is required.
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• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.