Cast Versus Surgery for Displaced Intra-Articular Distal Radius Fractures in the Elderly a Randomized Clinical Noninferiority Trial (the DART Study).

Abstract

Background: Evidence supporting surgery in elderly patients with distal radius fractures is limited, but displaced fractures may benefit from surgery. This study aimed to determine whether casting is noninferior to surgery for patients aged 65 years or older with substantially displaced intra-articular (AO type C) distal radius fractures.

Methods: This multicenter randomized controlled noninferiority trial included 138 patients (mean age 76 years, SD 6.0) in 19 Dutch hospitals. 138 patients were randomized with a mean age of 76 years (SD 6.0). After 12 months, 126 patients (91%) completed the trial. All patients had a nonacceptable fracture position according to the guideline after reduction. Patients were randomized between casting and open reduction internal fixation (ORIF). The primary outcome was the Patient Rated Wrist Evaluation (PRWE) at the 1-year follow-up. Secondary outcomes included the Disability of the Arm, Shoulder, and Hand questionnaire; quality of life (measured by the EQ-5D-3L); range of motion; grip strength; and complications. Primary analyses were linear mixed models with an intention-to-treat approach.

Results: The mean PRWE score at 1-year follow-up for the casting group was 20.4 (95% CI, 15.3-25.6) and in the surgical group was 14.5 (95% CI, 9.9-19.0). The primary intention-to-treat crude analysis was inconclusive regarding noninferiority, with a between-group difference of 6.0 points (95% CI, -2.1 to 14.1) in favor of surgery. However, noninferiority was demonstrated after correction for baseline covariates and in both as-treated analyses. The surgical group had better grip strength but significantly more reoperations (i.e., hardware removal). Subgroup analysis showed greater benefits of surgery in physiologically younger patients, while more frail patients had no advantage.

Conclusions: The primary analysis did not demonstrate noninferiority of casting compared with surgery at 1-year follow-up in patients aged 65 years or older with substantially displaced intra-articular distal radius fractures. The benefit of surgery was consistent across multiple outcomes, most notably in the short term and for physiologically younger patients.

Level of evidence: RCT. Level I evidence. See Instructions for Authors for a complete description of levels of evidence.