Nonoperative treatment versus volar locking plating for distal radius fracture in patients aged 65 years or older (DRIFT trial): A randomized controlled trial.

backgroundThe optimal management of distal radius fractures (DRFs) in older patients remains debatable. A knowledge gap exists concerning how to manage fractures with early malalignment during nonoperative treatment. We conducted a prospective, multicenter, and randomized controlled trial to compare nonoperative treatment to operative treatment with volar locking plating (VLP) in the management of primarily malaligned DRFs and DRFs that exhibit early malalignment during nonoperative treatment. METHODS AND

findingsThe DRIFT trial was conducted at five trauma centers in Finland, Sweden, and Denmark. Patients aged 65 years or older with a dorsally displaced AO-type A or C DRF were included in the trial. Patients with DRF who did not maintain alignment after closed reduction (CR) were randomized in 1:1 ratio to nonoperative treatment or VLP. Patients with acceptable alignment after CR visited the outpatient clinic 5-10 days after CR. If the alignment was lost, the patients were randomized in 1:1 ratio to either continue nonoperative treatment or to VLP. The primary outcome measure was Patient Rated Wrist Evaluation (PRWE) at 12 months. The primary analysis method for PRWE was a linear mixed model. In the linear mixed model, patient was a random factor and age and intra/extra articularity of the fracture were fixed. Participants and orthopedic investigators were not blinded. The statisticians and investigators responsible for the analysis remained blinded to the treatment groups during data analysis and the drawing of conclusions. Between March 15, 2018 and June 6, 2023, 291 patients aged 65 years or older (mean age 73 years (standard deviation (SD) 5.8), 258 women, 33 men) who had sustained a DRF were included in the trial. The 12-month follow-up was completed on June 11, 2024. One hundred twenty-four DRFs did not maintain acceptable fracture alignment after CR; 66 were randomized to nonoperative treatment and 58 to VLP. These patients are referred to as primarily malaligned DRFs. Eighty-six patients lost fracture alignment during the first 5-10 days of follow-up; 44 patients were randomized to continue nonoperative treatment, and 42 patients to VLP. These patients are referred to as early malaligned DRFs. In primarily malaligned DRFs, the estimated mean effect for PRWE at 12 months was -9.6 points (95% confidence interval (CI) [-17.4, -1.7]; p = 0.0178) in favor of VLP, which is smaller than the predefined minimal clinically important difference (MCID) of the PRWE (11 points). In early malaligned DRFs, the mean effect for PRWE at 12 months was -6.2 points (95% CI [-15.4, 3.0]; p = 0.1816). At 12-month follow-up, we found 25 treatment-related adverse events (AE) (10/66, 15% in primarily malaligned DRFs nonoperative; 5/58, 8.6% in primarily malaligned DRFs operative; 2/44, 4.5% in early malaligned DRFs nonoperative; 3/42, 7.1% in early malaligned DRFs operative; 5/63, 7.9% in well-aligned DRFs) and 11 other AE. The trial recruitment period was longer than expected due to the restrictions caused by the global COVID-19 pandemic. Due to the decreased inclusion rate, we had to cease the recruitment of patients with early malaligned DRF before reaching the predefined 57 patients per Arm, which was the main limitation of the trial.

conclusionsOperative treatment of primarily malaligned DRF with VLP may slightly improve wrist function at 12 months. The estimated mean difference between the groups was, however, smaller than the predefined MCID of the PRWE (11 points). In DRFs with early loss of alignment, operative treatment does not appear to provide benefit. Our results suggest that the choice of treatment modality should be made following primary fracture reduction because subsequent monitoring of fracture alignment does not offer any additional benefit in terms of expected wrist function. This questions the need for early radiographic follow-up during the nonoperative treatment.

trial registrationThe trial was registered at ClinicalTrials.gov (Identifier: NCT02879656, registration date 08/17/2016).