Gertraud Gradl1, Nadja Mielsch2, Martina Wendt2, Steffi Falk2, Thomas Mittlmeier2, Philip Gierer2, Georg Gradl3. 1. Department of Trauma and Reconstructive Surgery, Aachen University Medical Center, Pauwelstrasse 30, 52074 Aachen, Germany. 2. Department of Trauma- and Reconstructive Surgery, Surgical Clinic University of Rostock, Schillingallee 35, 18055 Rostock, Germany. 3. Department of Trauma- and Reconstructive Surgery, Surgical Clinic University of Rostock, Schillingallee 35, 18055 Rostock, Germany. Electronic address: georg.gradl@med.uni-rostock.de.
Abstract
BACKGROUND: Intramedullary techniques for stabilization of displaced distal radius fractures are now available. Purported benefits include limited soft tissue dissection while affording sufficient stability to allow early wrist motion. The primary null hypothesis of this randomized trial is that there is no significant difference with respect to functional outcome, pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of unstable dorsally displaced extra-articular fractures of the distal radius. METHODS: We conducted a single-centre, parallel-group trial, with unrestricted randomization. Patients with dorsally displaced extra-articular distal radius fractures were randomized to receive volar locking plate (n=72) fixation or intramedullary nailing (n=80). The outcome was measured on the basis of the Gartland and Werley and Castaing score; the pain level; the range of wrist motion; the rate of complications; and radiographic measurements including volar tilt and ulnar variance. Clinical and radiographic assessment was performed at 8 weeks, 6 months, 1 year and 2 years after the operation. RESULTS: There were no significant differences between groups in terms of range of motion, grip strength or the level of pain during the entire follow-up period (p>0.05). There was no significant difference between treatment groups with respect to volar tilt or ulnar variance (p>0.05). There was no significant difference in the complication rate between groups (p>0.05). CONCLUSIONS: The present study supports the view that intramedullary nail fixation and volar plate fixation for the treatment of displaced extra-articular distal radius fractures have equivalent radiographic and functional outcomes. LEVEL OF EVIDENCE: Level I therapeutic study.
RCT Entities:
BACKGROUND: Intramedullary techniques for stabilization of displaced distal radius fractures are now available. Purported benefits include limited soft tissue dissection while affording sufficient stability to allow early wrist motion. The primary null hypothesis of this randomized trial is that there is no significant difference with respect to functional outcome, pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of unstable dorsally displaced extra-articular fractures of the distal radius. METHODS: We conducted a single-centre, parallel-group trial, with unrestricted randomization. Patients with dorsally displaced extra-articular distal radius fractures were randomized to receive volar locking plate (n=72) fixation or intramedullary nailing (n=80). The outcome was measured on the basis of the Gartland and Werley and Castaing score; the pain level; the range of wrist motion; the rate of complications; and radiographic measurements including volar tilt and ulnar variance. Clinical and radiographic assessment was performed at 8 weeks, 6 months, 1 year and 2 years after the operation. RESULTS: There were no significant differences between groups in terms of range of motion, grip strength or the level of pain during the entire follow-up period (p>0.05). There was no significant difference between treatment groups with respect to volar tilt or ulnar variance (p>0.05). There was no significant difference in the complication rate between groups (p>0.05). CONCLUSIONS: The present study supports the view that intramedullary nail fixation and volar plate fixation for the treatment of displaced extra-articular distal radius fractures have equivalent radiographic and functional outcomes. LEVEL OF EVIDENCE: Level I therapeutic study.