Dataset Information

Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial.

ABSTRACT:

Objectives

To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.

Design

A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.

Setting

18 trauma centres in the United Kingdom.

Participants

461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.

Interventions

Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.

Main outcome measures

Primary outcome measure

validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100.

Secondary outcomes

disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.

Results

The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.

Conclusions

Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.

Trial registration

Current Controlled Trials ISCRTN 31379280. UKCRN 8956.

SUBMITTER: Costa ML

PROVIDER: S-EPMC4122170 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The use of low-profile dorsal and volar locking plates for distal radial fracture surgery has improved results and lowered the complication rate compared with older plate designs. The purpose of the present randomized controlled trial was to compare patient-reported outcomes as well as radiographic and functional results between patients who underwent stabilization with a volar locking plate or a dorsal locking nail-plate for the treatment of dorsally displaced unstable extra-articular distal radial fractures. One hundred and twenty patients ≥55 years of age were randomized to surgery with either a volar locking plate or a dorsal locking nail-plate and were assessed at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. The primary outcome was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. Secondary outcomes were the Patient-Rated Wrist Evaluation (PRWE), EuroQol 5 Dimensions (EQ-5D) index and visual analog scale (VAS), range of motion, grip strength, radiographic measurements, and complication rate. The median age was 66 years (range, 55 to 88 years). The rate of follow-up was 97%. There was no clinically important difference between the groups at any point during follow-up. Patients in the volar locking plate group had better mean QuickDASH scores at 6 weeks, 6 months, and 1 year. However, the differences were small (5.8 vs. 11.3 points at 1 year; mean difference, -5.5 points [95% confidence interval (CI), -9.9 to 1.2]; p = 0.014), which is lower than any proposed minimum clinically important difference (MCID). The difference in PRWE scores was also lower than the MCID (1.0 vs. 3.5 at 1 year; mean difference, -2.5 [95% CI, -4.4 to 0.6]; p = 0.012). The dorsal locking nail-plate group had slightly better restoration of volar tilt (p = 0.011). EQ-5D index, EQ-5D VAS, range of motion, grip strength, and complication rates were similar. We found no clinically relevant difference between the volar locking plate and dorsal locking nail-plate groups after 1 year or in the time period up to 1 year. A dorsal locking nail-plate can therefore be an alternative method for the treatment of these unstable fractures or in cases in which a dorsal approach is preferable over a volar approach. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:IntroductionOptimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures.Methods and analysisAdult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either 'manipulation and surgical fixation with K-wires' or 'manipulation and plaster casting'. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications.Ethics and disseminationThe National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.Trial registration numberISRCTN11980540; Pre-results.

Project description:BackgroundDistal radius fractures are common, costly, and increasing in incidence. Percutaneous K-wire fixation and volar locking plates are two of the most commonly used surgical treatments for unstable dorsally displaced distal radius fractures. However, there is uncertainty regarding which of these treatments is superior.Questions/purposesWe performed a meta-analysis of randomized controlled trials to determine whether patients treated with volar locking plates (1) achieved better function (2) attained better wrist motion, (3) had better radiographic outcomes, and (4) had fewer complications develop than did patients treated with K-wires for dorsally displaced distal radius fractures.MethodsWe performed a comprehensive search of MEDLINE (inception to 2014, October Week 2), EMBASE (inception to 2014, Week 42), and the Cochrane Central Register of Controlled Trials to identify relevant randomized controlled trials; we supplemented these searches with manual searches. We included studies of extraarticular and intraarticular distal radius fractures. Adjunctive external fixation was acceptable as long as the intent was to use only K-wires where possible and external fixation was used in less than 25% of the procedures. We considered a difference in the DASH scores of 10 as the minimal clinically important difference. We performed quality assessment with the Cochrane Risk of Bias tool and evaluated the strength of recommendations using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Seven randomized trials with a total of 875 participants were included in the meta-analysis.ResultsPatients treated with volar locking plates had slightly better function than did patients treated with K-wires as measured by their DASH scores at 3 months (mean difference [MD], 7.5; 95% CI, 4.4-10.6; p < 0.001) and 12 months (MD, 3.8; 95% CI, 1.2-6.3; p = 0.004). Neither of these differences exceeded the a priori-determined threshold for clinical importance (10 points). There was a small early advantage in flexion and supination in the volar locking plate group (3.7° [95% CI, 0.3°-7.1°; p = 0.04] and 4.1° [95% CI, 0.6°-7.6°; p = 0.02] greater, respectively) at 3 months, but not at later followups (6 or 12 months). There were no differences in radiographic outcomes (volar tilt, radial inclination, and radial height) between the two interventions. Superficial wound infection was more common in patients treated with K-wires (8.2% versus 3.2%; RR = 2.6; p = 0.001), but otherwise no difference in complication rates was found.ConclusionsDespite the small number of studies and the limitations inherent in a meta-analysis, we found that volar locking plates show better DASH scores at 3- and 12-month followups compared with K-wires for displaced distal radius fractures in adults; however, these differences were small and unlikely to be clinically important. Further research is required to better delineate if there are specific radiographic, injury, or patient characteristics that may benefit from volar locking plates in the short term and whether there are any differences in long-term outcomes and complications.Level of evidenceLevel I, therapeutic study.