Ola-Lars Hammer1,2, Ståle Clementsen1,2, Joakim Hast1, Jūratė Šaltytė Benth3,4, Jan Erik Madsen5,6, Per-Henrik Randsborg1. 1. Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway. 2. University of Oslo, Oslo, Norway. 3. Institute of Clinical Medicine, Campus Ahus, University of Oslo, Oslo, Norway. 4. Health Services Research Unit, Akershus University Hospital, Lørenskog, Norway. 5. Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway. 6. Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Abstract
BACKGROUND: The aim of the study was to compare the functional outcomes following fixation with a volar locking plate (VLP) with those outcomes after augmented external fixation (EF) of displaced, intra-articular distal radial fractures in patients 18 to 70 years of age. METHODS: Following inclusion, randomization, and surgery, clinical examination and outcome assessments were conducted at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, and secondary outcomes included wrist range of motion, grip strength, and pain assessed with a visual analog scale (VAS). RESULTS: Over a span of 3 years, 166 patients were included in the study. The mean age was 55.0 years (standard deviation [SD] = 11.5 years), with the ages distributed evenly in each treatment group by block randomization (84 patients in the VLP group and 82 in the EF group). The patients in the VLP group had a significantly better mean QuickDASH score, range of motion, and grip strength at 6 weeks, 12 weeks, 6 months, and 1 year. There were no significant differences between the groups at 2 years. On the basis of the minimal clinically important difference, the difference in the QuickDASH score was clinically relevant only at 6 weeks and arguably at 3 months (9.2 and 8.5 points, respectively). Therefore, the statistically significant improvement in the functional outcome of VLP compared with that of EF cannot be safely said to have clinical relevance beyond 12 weeks. The overall complication rate was comparable between the 2 groups. The rate of follow-up at 2 years was 97.0%. CONCLUSIONS:VLP fixation resulted in faster recovery of function compared with EF, but no functional advantage was demonstrated at 2 years. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
BACKGROUND: The aim of the study was to compare the functional outcomes following fixation with a volar locking plate (VLP) with those outcomes after augmented external fixation (EF) of displaced, intra-articular distal radial fractures in patients 18 to 70 years of age. METHODS: Following inclusion, randomization, and surgery, clinical examination and outcome assessments were conducted at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, and secondary outcomes included wrist range of motion, grip strength, and pain assessed with a visual analog scale (VAS). RESULTS: Over a span of 3 years, 166 patients were included in the study. The mean age was 55.0 years (standard deviation [SD] = 11.5 years), with the ages distributed evenly in each treatment group by block randomization (84 patients in the VLP group and 82 in the EF group). The patients in the VLP group had a significantly better mean QuickDASH score, range of motion, and grip strength at 6 weeks, 12 weeks, 6 months, and 1 year. There were no significant differences between the groups at 2 years. On the basis of the minimal clinically important difference, the difference in the QuickDASH score was clinically relevant only at 6 weeks and arguably at 3 months (9.2 and 8.5 points, respectively). Therefore, the statistically significant improvement in the functional outcome of VLP compared with that of EF cannot be safely said to have clinical relevance beyond 12 weeks. The overall complication rate was comparable between the 2 groups. The rate of follow-up at 2 years was 97.0%. CONCLUSIONS: VLP fixation resulted in faster recovery of function compared with EF, but no functional advantage was demonstrated at 2 years. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Authors: Trine Ludvigsen; Kjell Matre; Nils Vetti; Per Martin Kristoffersen; Monika Kolskår Toppe; Rakel Gudmundsdottir; Yngvar Krukhaug; Eva Dybvik; Jonas Meling Fevang Journal: OTA Int Date: 2021-08-09