Comparison of surgical and conservative treatments for distal radius fractures in the elderly: a multicenter, randomized, single-blind (DART study)

BACKGROUND: Distal radius fractures (DRFs) are a global public health issue and represent the second most common type of fracture among the elderly. There remains controversy in the orthopedic community regarding the optimal treatment strategy for DRFs. METHODS: We will conduct a multicenter, randomized, single-blind, controlled trial to assess the efficacy of surgical versus conservative treatment for distal radius fractures in elderly patients. Sample size calculations are based on the PRWE score, aiming to randomize 456 participants in a 1:1 ratio. Once randomized, patients will be followed for 24 months post-treatment. The primary outcome will be wrist function reported by patients within the first year post-injury. Secondary outcomes include QUICKDASH scores, VAS scores, EQ-5D-3L scores, range of wrist motion, grip strength, complications, and patient satisfaction. Additionally, the study will evaluate the economic and social benefits using statistical methods. DISCUSSION: There is no definitive answer as to whether elderly patients with displaced distal radius fractures universally benefit from surgery. However, current literature suggests that surgery does not provide significant advantages. Through this study, we aim to provide the highest quality evidence to determine the optimal treatment strategy for distal radius fractures in patients aged 60 and above, thereby enhancing post-trauma recovery for the elderly. TRIAL REGISTRATION: This study had been registered in the Chinese Clinical Trials Registry. REGISTRATION NUMBER: ChiCTR2400080223 on January 24, 2024. https://www.chictr.org.cn .