Hemiarthroplasty versus nonoperative treatment of comminuted proximal humeral fractures: results of the ProCon multicenter randomized clinical trial.

BACKGROUND/AIM: The best treatment of comminuted, proximal humeral fractures in the elderly population is an unresolved clinical problem. This study aimed to compare the outcome of hemiarthroplasty (HA) and nonoperative treatment in the elderly population patients with a comminuted proximal humeral fracture.

METHOD: From October 6, 2009 to April 26, 2017, 57 elderly patients with a comminuted proximal humeral fracture were enrolled in the multicenter randomized controlled trial (RCT). Patients were randomized to HA or nonoperative treatment. Outcome measures were the Constant-Murley score (primary outcome), Disabilities of the Arm, Shoulder, and Hand, pain (Visual Analog Score), quality of life (Short Form-36 and EuroQoL-5D-3 L), complications, revision operation, health care consumption, and costs. Patients were followed for two years.

RESULT: Of the 57 patients included, 30 underwent treatment with HA and 27 were treated nonoperatively. Patients had a median age of 77 years, and 89 % was female. According to the Hertel classification, most fractures were type 7 (47 %) or type 12 (42 %). The median Constant-Murley score increased from 23 (95 % CI 17-29) at six weeks to 48 (95 % CI 41-53) at 24 months in the HA group, and from 24 (95 % CI 17-31) to 59 (95 % CI 52-65) in the nonoperative group. Throughout follow-up, scores were similar in both groups. The DASH score consistently decreased over time in both groups. At 24 months, median DASH scores were 24.0 (95 % CI 17.4-30.8) and 23.4 (95 % CI 16.5-30.4) in the HA and nonoperative group, respectively. Pain levels, SF-36, and EQ-5D were similar in both groups throughout follow-up. Eleven patients, of which seven in the HA group, developed one or more complications, of which six patients required surgical interventions. Total costs were higher for HA, although not statistically significant.

CONCLUSION

Based on results of this RCT, primary hemiarthroplasty cannot be considered superior to nonoperative treatment for comminuted proximal humeral fractures in the elderly population. A trend favoring nonoperative treatment is observed in outcomes and in costs.