A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years

BACKGROUND: Distal radius fractures (DRF) are very common in elderly patients, who present at the Emergency Department. Surgical treatment with open reduction and internal fixation using volar locking plates is widely prevalent despite the lack of evidence proving its superiority to conservative treatment with closed reduction and plaster immobilization. The purpose of this study is to investigate whether conservative treatment is superior to volar plating in terms of number of complications and results in a comparable or superior functional outcome in patients ≥65 years. METHODS: In this single-center, single-blinded randomized-controlled trial, patients ≥65 years with distal radius fractures will be invited to participate. A total of 50 patients per treatment arm is required to provide 80% statistical power at a 5% alpha level assuming a difference of 20% in complication rate between operatively and conservatively treated patients. Primary outcome measures will be complication rate, Quick DASH score (Quick Disabilities of the Arm, Shoulder and Hand), PRWE (Patient rated Wrist evaluation), and range of motion of the wrist. Secondary outcome measures will be grip strength, pinch gauge, pain, use of pain medication EQ5D score (European Quality of life – 5 dimensions), standardized radiographs. One year of follow-up is planned with data collection at the day of injury, after 2 weeks, after 5 weeks, after 6 months, and after 12 months. An intention-totreat and per-protocol analysis will be performed. DISCUSSION: This prospective trial helps to clarify the best treatment strategy for displaced DRF patients ≥65 years. TRIAL REGISTRATION: This trial is approved by the Danish Scientific Ethical Committee (ID: 1–10–72-420-17) and registered at Clinicaltrials.gov (Trial registration number NCT03716661).