VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years

Abstract

Background: Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes. Materials and methods: A single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting. Primary outcome: complications assessed after 2 and 5 weeks and 6 and 12 months. Secondary outcomes: Quick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L. Results: 148 patients were screened from November 2019 to March 2021. 48 patients did not want to participate or were unable to participate in the follow-up. 100 patients were randomized and 85 patients were available for full analysis due to there being 4 deaths, 6 withdrawals, 1 wrong inclusion, 1 emigration, 1 refracture, 1 patient with compartment syndrome, and 1 who was advised to undergo surgery after being randomized to non-operative treatment. Median age was 74 years (range 65–92), 81 women/19 men, 42 right/58 left side, 87 retired, 11 smokers, 86 ASA class 1 or 2. Complication rates did not statistical significantly vary between the operative and non-operative group: 20.9% (9/43) vs 16.6% (7/42), p = 0.78 (Fisher’s exact test). Complications were driven by sensory disturbances. Four reoperations were performed: two in the non-operative group: carpal tunnel syndrome; two in the operative group: one carpal tunnel syndrome, one protruding screw causing extensor tendon irritation. Mean difference in Quick-DASH varied from 2.3 (95% CI − 3 to 8) pre-injury to 4.2 (− 4 to 12) at 12 months. Quick-DASH and PRWHE were neither statistically nor clinically-relevant different between groups. Conclusions: Complication rates after operative and non-operative treatment of DRF were similar. Volar plating did not improve the functional outcome after 5 weeks, 6 months, and 12 months. These findings are in line with recent RCTs and mandate a revision of guidelines towards more conservative treatment. Take home messages: (1) consider non-operative treatment in elderly patients sustaining unstable DRFs; (2) choosing operative treatment in patients older than 65 years should not be the gold standard; (3) however, non-operative treatment still carries a risk for complications. Level of evidence: II. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306.