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Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. The purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after ORIF with and without an additional wrist arthroscopy in adult patients with displaced complete articular distal radius fractures. METHODS:In this multicentre trial, adult patients with a displaced complete articular distal radius fracture are randomised between ORIF with an additional wrist arthroscopy to remove fracture haematoma and debris (intervention group) and conventional fluoroscopic-assisted ORIF (control group). The primary outcome is functional outcome assessed with the PRWE score after three months. Secondary outcomes are wrist function assessed with the Disability of the Arm, Shoulder and Hand (DASH) score, postoperative pain, range of motion, grip strength, complications and cost-effectiveness. Additionally, in the intervention group, the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. A total of 50 patients will be included in this study. DISCUSSION:Although ORIF of intra-articular distal radius fractures leads to a quicker resume of function compared to non-operative treatment, some patients continue to have a painful and stiff wrist postoperatively. We hypothesise that, due to the removal of fracture haematoma and debris by an additional arthroscopy, functional outcomes will be better compared to the non-arthroscopically treated group. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02660515 . Registered on 13 January 2016.

SUBMITTER: Mulders MAM

PROVIDER: S-EPMC5797370 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial.

Mulders Marjolein A M MAM Selles Caroline A CA Colaris Joost W JW Peters Rolf W RW van Heijl Mark M Cleffken Berry I BI Schep Niels W L NWL

Trials 20180202 1

<h4>Background</h4>In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra ...[more]

PMID: 29394904

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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.

Project description:IntroductionDistal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.Methods and analysisTo test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).Ethics and disseminationThe protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.Trial registration numberDutch Trial Registry (NTR), NL6140, protocol V.2.

Project description:ImportanceNo consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift.ObjectivesTo compare functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radius fractures in adults.Data sourcesThe PubMed/MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception to June 15, 2019, for studies comparing operative vs nonoperative treatment of distal radius fractures.Study selectionRandomized clinical trials (RCTs) and observational studies reporting on the following: acute distal radius fracture with operative treatment (internal or external fixation) vs nonoperative treatment (cast immobilization, splinting, or bracing); patients 18 years or older; and functional outcome. Studies in a language other than English or reporting treatment for refracture were excluded.Data extraction and synthesisData extraction was performed independently by 2 reviewers. Effect estimates were pooled using random-effects models and presented as risk ratios (RRs) or mean differences (MDs) with 95% CIs. Data were analyzed in September 2019.Main outcomes and measuresThe primary outcome measures included medium-term functional outcome measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) and the overall complication rate after operative and nonoperative treatment.ResultsA total of 23 unique studies were included, consisting of 8 RCTs and 15 observational studies, that described 2254 unique patients. Among the studies that presented sex data, 1769 patients were women [80.6%]. Overall weighted mean age was 67 [range, 22-90] years). The RCTs included 656 patients (29.1%); observational studies, 1598 patients (70.9%). The overall pooled effect estimates the showed a significant improvement in medium-term (≤1 year) DASH score after operative treatment compared with nonoperative treatment (MD, -5.22 [95% CI, -8.87 to -1.57]; P = .005; I2 = 84%). No difference in complication rate was observed (RR, 1.03 [95% CI, 0.69-1.55]; P = .87; I2 = 62%). A significant improvement in grip strength was noted after operative treatment, measured in kilograms (MD, 2.73 [95% CI, 0.15-5.32]; P = .04; I2 = 79%) and as a percentage of the unaffected side (MD, 8.21 [95% CI, 2.26-14.15]; P = .007; I2 = 76%). No improvement in medium-term DASH score was found in the subgroup of studies that only included patients 60 years or older (MD, -0.98 [95% CI, -3.52 to 1.57]; P = .45; I2 = 34%]), compared with a larger improvement in medium-term DASH score after operative treatment in the other studies that included patients 18 years or older (MD, -7.50 [95% CI, -12.40 to -2.60]; P = .003; I2 = 77%); the difference between these subgroups was statically significant (test for subgroup differences, P = .02).Conclusions and relevanceThis meta-analysis suggests that operative treatment of distal radius fractures improves the medium-term DASH score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. The findings suggest that operative treatment might be more effective and have a greater effect on the health and well-being of younger, nonelderly patients.

Project description:Background The current literature does not contain a quantitative description of the associations between operative time and adverse outcomes after open reduction and internal fixation (ORIF) of distal radial fractures (DRF). Questions/Purpose We aimed to quantify associations between DRF ORIF operative time and 1) 30-day postoperative health care utilization and 2) the incidence of local wound complications. Methods The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was queried for DRF ORIF cases (January 2012-December 2018). A total of 17,482 cases were identified. Primary outcomes included health care utilization (length of stay [LOS], discharge dispositions, 30-day readmissions, and reoperations) per operative-time category. Secondary outcome was incidence of wound complications per operative-time category. Multivariate regression was conducted to determine operative-time categories associated with increased risk while adjusting for demographics, comorbidities, and fracture type. Spline regression models were constructed to visualize associations. Results The 121 to 140-minute category was associated with significantly higher risk of a LOS > 2 days (odds ration [OR]: 1.64; 95% confidence interval [CI]:1.1-2.45; p = 0.014) and nonhome discharge (OR: 1.72; 95% CI:1.09-2.72; p = 0.02) versus 41 to 60-minute category. The ≥ 180-minute category exhibited highest odds of LOS > 2 days (OR: 2.08; 95%CI: 1.33-3.26; p = 0.001), nonhome discharge disposition (OR: 1.87; 95% CI: 1.05-3.33; p = 0.035), and 30-day reoperation occurrence (OR: 3.52; 95% CI: 1.59-7.79; p = 0.002). There was no association between operative time and 30-day readmission ( p > 0.05 each). Higher odds of any-wound complication was first detected at 81 to 100-minute category (OR: 3.02; 95% CI: 1.08-8.4; p = 0.035) and peaked ≥ 181 minutes (OR: 9.62; 95% CI: 2.57-36.0; p = 0.001). Spline regression demonstrated no increase in risk of adverse outcomes if operative times were 50 minutes or less. Conclusion Our findings demonstrate that prolonged operative time is correlated with increased odds of health care utilization and wound complications after DRF ORIF. Operative times greater than 60 minutes seem to carry higher odds of postoperative complications.

Project description:BackgroundDistal radius fractures are the most frequently encountered fractures in Western societies, typically affecting patients aged 50 years and older. Although this is a common injury, the best treatment for these fractures in older patients is still under debate.ObjectiveThis prospective study aims to compare the outcome of operatively and nonoperatively treated distal radius fractures in the older population. Only patients with distal radius fractures for which equipoise regarding the optimal treatment exists will be included.MethodsThis prospective international multicenter observational cohort study will be designed as a natural experiment. Natural experiments are observational studies in which treatment allocation is determined by factors outside the control of the investigators but also (largely) independent of patient characteristics. Patients aged 65 years and older with an acute distal radius fracture will be considered for inclusion. Treatment allocation (operative vs nonoperative) will be based on the local preferences of the treating hospital either in Switzerland or the Netherlands. Hence, the process governing treatment allocation resembles that of randomization. Patients will be identified after treatment has been initiated. Based on the radiographs and baseline information of the patient, an expert panel of 6 certified trauma surgeons from 2 regions will provide their treatment recommendation. Only patients for whom the experts disagree on treatment recommendations will ultimately be included in the study (ie, for whom there is a clinical equipoise). For these patients, both operative and nonoperative treatment of distal radius fractures are viable, and treatment choice is predominantly determined by personal or local preference. The primary outcome will be the Patient-Rated Wrist Evaluation score at 12 weeks. Secondary outcomes will include the Physical Activity Score for the Elderly, the EQ questionnaire, pain, the living situation, range of motion, complications, and radiological outcomes. By including outcomes such as living situation and the Physical Activity Score for the Elderly, which are not relevant for younger cohorts, valuable information to tailor treatment to the needs of the older population can be gained. According to the sample size collection, which was based on the minimal important clinical difference of the Patient-Rated Wrist Evaluation, 92 patients will have to be included, with at least 46 patients in each treatment group.ResultsEnrollment began in July 2023 and is expected to continue until summer 2024. The final follow-up will be 2 years after the last patient is included.ConclusionsAlthough many trials on this topic have previously been published, there remains an ongoing debate regarding the optimal treatment for distal radius fractures in older patients. This observational study, which will use a fairly new methodological study design, will provide further information on treatment outcomes for older patients with distal radius fractures for which to date equipoise exists regarding the optimal treatment.International registered report identifier (irrid)DERR1-10.2196/52917.

Dataset Information

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial.

Publications

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial.

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