Marjolein A M Mulders1, Monique M J Walenkamp1, Susan van Dieren1, J Carel Goslings2, Niels W L Schep3. 1. Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 2. Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 3. Department of Hand and Trauma Surgery, Maasstad Hospital, Rotterdam, the Netherlands.
Abstract
BACKGROUND: There is no consensus as to whether displaced extra-articular distal radial fractures should be treated operatively or nonoperatively. We compared the outcomes of open reduction and volar plate fixation with closed reduction and plaster immobilization in adults with an acceptably reduced extra-articular distal radial fracture. METHODS: In this multicenter randomized controlled trial, patients 18 to 75 years old with an acceptably reduced extra-articular distal radial fracture were randomly assigned to open reduction and volar plate fixation or plaster immobilization. The primary outcome was function as measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire after 12 months. Follow-up was conducted at 1, 3, and 6 weeks and at 3, 6, and 12 months. Analyses were performed according to the intention-to-treat principle. RESULTS: Ninety-two patients were randomized, 48 to open reduction and volar plate fixation and 44 to plaster immobilization; 1 patient in each group was excluded for withdrawing informed consent. At all follow-up time points, operatively treated patients had significantly better functional outcomes, as indicated by significantly lower DASH scores, than patients treated nonoperatively (all p values < 0.05). Twelve nonoperatively managed patients (28%) had fracture redisplacement within 6 weeks and underwent subsequent open reduction and internal fixation, and 6 patients (14%) had a symptomatic malunion treated with corrective osteotomy. CONCLUSIONS:Patients with an acceptably reduced extra-articular distal radial fracture treated withopen reduction and volar plate fixation have better functional outcomes after 12 months compared with nonoperatively managed patients. Additionally, 42% of nonoperatively managed patients had a subsequent surgical procedure. Open reduction and volar plate fixation should be considered for patients who experience this common injury. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND: There is no consensus as to whether displaced extra-articular distal radial fractures should be treated operatively or nonoperatively. We compared the outcomes of open reduction and volar plate fixation with closed reduction and plaster immobilization in adults with an acceptably reduced extra-articular distal radial fracture. METHODS: In this multicenter randomized controlled trial, patients 18 to 75 years old with an acceptably reduced extra-articular distal radial fracture were randomly assigned to open reduction and volar plate fixation or plaster immobilization. The primary outcome was function as measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire after 12 months. Follow-up was conducted at 1, 3, and 6 weeks and at 3, 6, and 12 months. Analyses were performed according to the intention-to-treat principle. RESULTS: Ninety-two patients were randomized, 48 to open reduction and volar plate fixation and 44 to plaster immobilization; 1 patient in each group was excluded for withdrawing informed consent. At all follow-up time points, operatively treated patients had significantly better functional outcomes, as indicated by significantly lower DASH scores, than patients treated nonoperatively (all p values < 0.05). Twelve nonoperatively managed patients (28%) had fracture redisplacement within 6 weeks and underwent subsequent open reduction and internal fixation, and 6 patients (14%) had a symptomatic malunion treated with corrective osteotomy. CONCLUSIONS:Patients with an acceptably reduced extra-articular distal radial fracture treated with open reduction and volar plate fixation have better functional outcomes after 12 months compared with nonoperatively managed patients. Additionally, 42% of nonoperatively managed patients had a subsequent surgical procedure. Open reduction and volar plate fixation should be considered for patients who experience this common injury. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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