Dataset Information

Volar Locking Plate Versus Dorsal Locking Nail-Plate Fixation for Dorsally Displaced Unstable Extra-Articular Distal Radial Fractures: Functional and Radiographic Results from a Randomized Controlled Trial.

ABSTRACT: 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.

Methods

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.

Results

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.

Conclusions

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.

Level of evidence

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Eikrem M

PROVIDER: S-EPMC8509916 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.DesignA multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.Setting18 trauma centres in the United Kingdom.Participants461 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.InterventionsKirschner 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 measuresPrimary outcome measurevalidated 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 outcomesdisabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.ResultsThe 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.ConclusionsContrary 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 registrationCurrent Controlled Trials ISCRTN 31379280. UKCRN 8956.

Project description:BackgroundSurgical treatment of displaced distal radius fractures (DRF) in older patients has increased, despite lacking evidence of its superiority over non-operative treatment. How treatment choice affects these patients after the initial 12-month period remains unknown. This study presents a clinical and radiographic follow up at an average of 3 years after treatment in the context of a randomized clinical trial comparing outcomes in patients aged ≥70 years, with a dorsally displaced distal radius fracture treated either surgically with volar locking plate or non-operatively.MethodsBetween 2009 and 2017, 140 patients aged ≥70 years with dorsally displaced DRF were randomized to surgery with volar locking plate (VLP) or non-operative treatment. At an average of 3 years after inclusion the participants were invited to an additional follow-up. The primary outcome was Patient Rated Wrist Evaluation (PRWE). Secondary outcomes included additional Patient Reported Outcome Measures (PROM), grip strength, range of motion, complications and radiological results.ResultsSixty six patients were available for a 3 year follow-up, 33 in the non-operatively treated group and 33 in the VLP-group. The mean age at injury was 77 years. At 3 years the median PRWE was better (0 points) in the VLP-group than in the non-operative treatment group (9 points) p-value: 0.027. No statistically significant difference was found in Disabilities of the Arm, Hand, and Shoulder (DASH), EuroQol 5 Dimensions (EQ-5D) or grip strength. Total arc of range of motion was larger in the operatively treated group. No significant difference in osteoarthritis was found. Both groups had regained grip strength. The complication rate was similar. Outcomes improved from the 1 year to the 3 year follow-up.ConclusionsSurgery with volar locking plate gave less long-term disability compared to non-operative treatment for severely displaced distal radius fractures in patients aged ≥70 years. Our findings were statistically significant but in the lower range of clinical importance.Trial registrationThe study was registered at : NCT02154620 03/06/2014 and NCT01268397 30/12/2010. Ethical approval was obtained from Ethical Committee in Stockholm, Sweden (2009/37-31/3, 2013/105-31/2, 2014/1041-32, 2017/611-32).

Project description:The aim of this study was to test the hypothesis that precise restoration of distal radius fractures is correlated to better patient-reported outcome.MethodsThe correlation between radiographic results and functional outcome was explored in 156 patients with extra-articular distal radius fractures included in a multicenter, randomized controlled trial comparing 2 surgical interventions, Volar Locking Plate or External Fixator. The primary functional outcome was the Patient Rated Wrist and Hand Evaluation score (PRWHE). Radiographically we assessed volar tilt, radial inclination, radial height, ulnar variance, and the presence of ulnar styloid fracture. The Pearson correlation analysis was used to estimate correlations between parameters.ResultsAt 1-year follow-up the mean difference in radiographic findings compared with the uninjured side (min, max) was: reduced volar tilt 5.3° (-15°, 25°), reduced radial inclination 2.3° (-6°, 12°), radial height 1.3 mm (-4 mm, 7 mm), and ulnar variance -0.5 mm (-6 mm, 3 mm). Overall, we found no correlation between radiographic parameters and the PRWHE at 1-year follow-up within the whole group, regardless of which treatment was chosen. At the time of injury 53% (N = 80) had sustained an additional ulnar styloid fracture. After 1 year this fracture was still radiographically present in 31% (N = 43) of the patients. No correlation between PRWHE score and the presence of an ulnar styloid fracture at 1-year follow-up was found.ConclusionsWe found no correlation between functional outcome (PRWHE) and radiographic findings after 1 year in patients operated on with a Volar Locking Plate or External Fixator. Patient-specific factors were more important than radiographic measurements in this study group.Level of evidence: Therapeutic Level 2Trial registration: Norway: National Committee for Medical and Health Research Ethics 213/555ClinicalTrials.gov ID: NCT01904084Randomization of first patient: 02.09.2013.