Operative vs Nonoperative Management of Fractures of the Humeral Diaphysis: The Humeral Shaft Fracture Fixation Randomized Clinical Trial.

IMPORTANCE

Humeral shaft fractures are routinely managed nonoperatively, but this approach is potentially associated with higher nonunion rates and inferior functional outcomes when compared with operative fixation.

OBJECTIVE

To assess whether there is any difference in outcome between surgery and functional bracing for adults with an isolated, closed humeral shaft fracture.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, superiority, parallel-group randomized clinical trial was conducted between September 2018 and October 2023 and took place at an academic major trauma center in the United Kingdom. Patients were reviewed at 2 and 6 weeks and 3, 6, and 12 months postintervention. Patients included 70 adults with an isolated, closed humeral shaft fracture. Exclusion criteria included absolute indications for surgery, pathological/periprosthetic fractures, multiple traumas, significant frailty, and inability to comply with follow-up. Data were analyzed from November 2023 through January 2024.

INTERVENTIONS

Open reduction and plate fixation (n = 36) or functional bracing (n = 34). Seven patients did not receive their assigned treatment (operative, 5; nonoperative, 2).

MAIN OUTCOMES AND MEASURES

The primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand score (DASH) at 3 months postintervention. Secondary outcomes included health-related quality of life (EuroQol 5-Dimension [EQ-5D]/health visual analog scale [EQ-VAS] and Short Form [SF]-12 Physical Component Summary [PCS]/Mental Component Summary [MCS] scores), pain, shoulder/elbow range of motion, and complications. Intention-to-treat analyses were used.

RESULTS

The study included 70 patients (mean [SD] age, 49 [17.1] years; 38 female [54%] and 32 male [46%]). At 3 months, 66 patients (94%) had completed follow-up. The operative group had a significantly better DASH score (difference, 15.0; P = .01). Surgery was also associated with a superior DASH score at 6 weeks (difference, 14.7; P = .01), but not at 6 months (P = .10) or at 12 months (P = .78). Surgery was further associated with a higher EQ-5D score (6 weeks: difference, 0.126, P = .03), EQ-VAS score (6 months: difference, 7; P = .04), and SF-12 MCS score (6 weeks: difference, 9.3; P = .001; 3 months: difference, 6.9; P = .01; and 6 months: difference, 7.1; P = .01). Brace-related dermatitis was significantly more common in the nonoperative group (18% vs operative 3%; P = .05). There were 8 nonunions (11%; operative 6% vs nonoperative 18%, P = .14).

CONCLUSIONS AND RELEVANCE

For patients with a humeral shaft fracture in this study, surgery conferred early functional advantages over bracing. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in outcomes at 1 year.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03689335.