Dataset Information

Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.

ABSTRACT: AIM:To investigate the cost-effectiveness of Volar Locking Plate (VLP) compared to External Fixation (EF) for unstable dorsally displaced distal radius fractures in a 3-year perspective. METHODS:During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture were randomised to VLP or EF. Primary outcome was the incremental cost-effectiveness ratio (ICER) for VLP compared with EF. Data regarding health effects (Quality-adjusted life years, QALYs) was prospectively collected during the trial period until 3 years after surgery. Cost data was collected retrospectively for the same time period and included direct and indirect costs (production loss). RESULTS:One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis. At one year, the VLP group had a mean incremental cost of 878 euros and a gain of 0.020 QALYs compared with the EF group, rendering an ICER of 43 900 euros per QALY. At three years, the VLP group had a mean incremental cost of 1 082 euros and a negative incremental effect of -0.005 QALYs compared to the EF group, which means that VLP was dominated by EF. The probability that VLP was cost-effective compared to EF at three years, was lower than 50% independent of the willingness to pay per QALY. CONCLUSION:Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF. Our results indicate that it is uncertain if VLP is a cost-effective treatment of unstable distal radius fractures compared to EF.

SUBMITTER: Saving J

PROVIDER: S-EPMC7544026 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.

Saving Jenny J Heintz Emelie E Pettersson Hans H Enocson Anders A Mellstrand Navarro Cecilia C

PloS one 20201008 10

<h4>Aim</h4>To investigate the cost-effectiveness of Volar Locking Plate (VLP) compared to External Fixation (EF) for unstable dorsally displaced distal radius fractures in a 3-year perspective.<h4>Methods</h4>During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture were randomised to VLP or EF. Primary outcome was the incremental cost-effectiveness ratio (ICER) for VLP compared with EF. Data regarding health effects (Quality-adjusted life years, QAL ...[more]

PMID: 33031472

Similar Datasets

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: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: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:Of all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture.This multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study.Although displaced intra-articular distal radius fractures are common, there is still no evidence on the optimal treatment for these fractures in patients aged 18 to 65 years. Therefore we aim to determine the difference in functional outcome between open reduction and plate fixation and closed reduction and plaster immobilisation.This study is registered at ClinicalTrials.gov ( NCT02651779 ) on January 4(th) 2016.

Dataset Information

Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.

Publications

Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets