Reverse shoulder arthroplasty or nothing for patients with displaced proximal humeral fractures: a randomized controlled trial.

ABSTRACT

BACKGROUND: The benefits of reverse shoulder arthroplasty compared to nonoperative treatment for patients presenting with complex proximal fractures have been rarely explored. The aim of this prospective study was to compare the functional results of reverse shoulder arthroplasty with those of nonsurgical treatment in patients with displaced proximal humeral fractures. METHODS: A multicentric prospective randomized control trial of patients older than 70 years who sustained an acute proximal humeral fracture (3 or 4 parts), with less than 3 weeks of evolution, and had no previous condition or surgery on the affected shoulder was conducted. Patients were randomly assigned to the intervention group (implantation of a reverse shoulder arthroplasty and tuberosities reattachment) or the control group (nonoperative treatment). Functional outcome was assessed using the Constant-Murley score (CMS) at the 1-year follow-up. Complications and reinterventions were considered secondary outcomes. The power of the study relied on the inclusion of 81 patients to recognize a statistically significant difference of 10 points between CMS scores in the groups. Analysis was performed based on the intention to treat principle. RESULTS: Eighty-one patients were randomized to surgical treatment or nonoperative treatment, while 66 patients completed the 1-year follow-up evaluation. There was no significant difference between the groups in terms of age (76.1 yo vs. 77.43 yo, P = .43), sex (81.08% women in the surgical group vs. 84.09% in the nonoperative group, P = .72), or type of fracture according to Neer's classification system (P = .06). At the 1-year follow-up, the group assigned to undergo the intervention had better functional outcomes than the nonoperative treatment group (mean CMS; 61.24, SD 13.33 vs. mean CMS 52.44, SD 16.22, P .02), with a mean difference of 8.84 points, 95% CI (1.57, 16.11). Two patients in the intervention group (6.5%) suffered major complications (periprosthetic joint infection and axillary nerve palsy). No major complications were observed in the nonoperative group. One patient in the intervention group underwent secondary surgery for a periprosthetic joint infection. CONCLUSIONS: Treatment with reverse shoulder arthroplasty provides superior functional outcomes compared with conservative treatment for patients presenting with an acute proximal humeral fracture. The difference in CMS is close to the clinically significant thresholds, and some harms are associated with the operative treatment.