Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study).

INTRODUCTION: Current literature is inconclusive about the optimal treatment of elderly patients with displaced intra-articular distal radius fractures. Cast treatment is less invasive and less expensive than surgical treatment. Nevertheless, surgery is often the preferred treatment for this common type of distal radius fracture. Patients with a non-acceptable position after closed reduction are more likely to benefit from surgery than patients with an acceptable position after closed reduction. Therefore, this study aims to assess non-inferiority of functional outcomes after casting versus surgery in elderly patients with a non-acceptable position following a distal radius fracture. METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial (RCT) with a non-inferiority design and an economic evaluation alongside. The population consists of patients aged 65 years and older with a displaced intra-articular distal radius fracture with non-acceptable radiological characteristics following either inadequate reduction or redisplacement after adequate reduction. Patients will be randomised between surgical treatment (open reduction and internal fixation) and non-operative treatment (closed reduction followed by cast treatment). We will use two age strata (65-75 and >75 years of age) and a web-based mixed block randomisation. A total of 154 patients will be enrolled and evaluated with the patient-rated wrist evaluation as the primary outcome at 1-year follow-up. Secondary outcomes include the Disabilities of the Arm, Shoulder and Hand questionnaire, quality of life (measured by the EQ-5D), wrist range of motion, grip strength and adverse events. In addition, we will perform a cost-effectiveness and cost-utility analysis from a societal and healthcare perspective. Incremental cost-effectiveness ratios, cost-effectiveness planes and cost-effectiveness acceptability curves will be presented. ETHICS AND DISSEMINATION: The Research and Ethics Committee approved this RCT (NL56858.100.16). The results of this study will be reported in a peer-reviewed journal. We will present the results of this study at (inter)national conferences and disseminate the results through guideline committees. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03009890). Dutch Trial Registry (NTR6365).

Cost Analysis of Volar Plate Fixation Versus Plaster Cast Immobilization for Intra-Articular Distal Radial Fractures.

BACKGROUND: The aim of this study was to compare the cost-effectiveness and cost-utility between plaster cast immobilization and volar plate fixation for acceptably reduced intra-articular distal radial fractures. METHODS: A cost-effectiveness analysis was conducted as part of a randomized controlled trial comparing operative (volar plate fixation) with nonoperative (plaster cast immobilization) treatment in patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Health-care utilization and use of resources per patient were documented prospectively and included direct medical costs, direct non-medical costs, and indirect costs. All analyses were performed according to the intention-to-treat principle. RESULTS: The mean total cost per patient was $291 (95% bias-corrected and accelerated confidence interval [bcaCI] = -$1,286 to $1,572) higher in the operative group compared with the nonoperative group. The mean total number of quality-adjusted life-years (QALYs) gained at 12 months was significantly higher in the operative group than in the nonoperative group (mean difference = 0.15; 95% bcaCI = 0.056 to 0.243). The difference in the cost per QALY (incremental cost-effectiveness ratio [ICER]) was $2,008 (95% bcaCI = -$9,608 to $18,222) for the operative group compared with the nonoperative group, which means that operative treatment is more effective but also more expensive. Subgroup analysis including only patients with a paid job showed that the ICER was -$3,500 per QALY for the operative group with a paid job compared with the nonoperative group with a paid job, meaning that operative treatment is more effective and less expensive for patients with a paid job. CONCLUSIONS: The difference in QALYs gained for the operatively treated group was equivalent to an additional 55 days of perfect health per year. In adult patients with an acceptably reduced intra-articular distal radial fracture, operative treatment is a cost-effective intervention, especially in patients with paid employment. Operative treatment is slightly more expensive than nonoperative treatment but provides better functional results and a better quality of life. LEVEL OF EVIDENCE: Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.

Volar Plate Fixation Versus Cast Immobilization in Acceptably Reduced Intra-Articular Distal Radial Fractures: A Randomized Controlled Trial.

BACKGROUND: The evidence for the treatment of acceptably reduced intra-articular distal radial fractures remains inconclusive. We therefore compared the functional outcomes of cast immobilization (nonoperative) and volar plate fixation (operative) for patients with these fractures. METHODS: This multicenter randomized controlled trial enrolled patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Patients were randomized to nonoperative treatment or to operative treatment. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after 12 months. Secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Short Form-36 (SF-36) questionnaire; a visual analog scale for pain; range of motion; grip strength; radiographic parameters; and complications. Analyses followed the intention-to-treat principle. RESULTS: A total of 96 patients were randomized, and 90 (46 in the nonoperative group and 44 in the operative group) were included in the analysis. Patients treated in the operative group had significantly better functional outcomes measured with the PRWE at 6 weeks, 3 months, 6 months, and 1 year. Additionally, a 28% rate of subsequent surgery was identified in the nonoperative group. CONCLUSIONS: Adult patients with an acceptably reduced intra-articular distal radial fracture have better functional outcomes for 12 months when treated operatively instead of nonoperatively. We therefore recommend surgical treatment for patients with these fractures. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Functional Outcomes after Corrective Osteotomy of Symptomatic Distal Radius Malunions in Children.

Background Closed reduction and cast immobilization of displaced distal radius fractures carries the risk of secondary displacement, which could result in a symptomatic malunion. In patients with a symptomatic malunion, a corrective osteotomy can be performed to improve pain and functional impairment of the wrist joint. Objective The aim of this study was to assess the functional outcomes of children who underwent a corrective osteotomy due to a symptomatic malunion of the distal radius. Methods Between 2009 and 2016, all consecutive corrective osteotomies of the distal radius of patients younger than 18 years were reviewed. The primary outcome was functional outcome assessed with the ABILHAND-Kids score. Secondary outcomes were QuickDASH (Quick Disabilities of Arm, Shoulder, and Hand) score, range of motion, complications, and radiological outcomes. Results A total of 13 patients with a median age of 13 years (interquartile range [IQR]: 12.5-16) were included. The median time to follow-up was 31 months (IQR: 26-51). The median ABILHAND-Kids score was 42 (range: 37-42), and the median QuickDASH was 0 (range: 0-39). Range of motion did not differ significantly between the injured and the uninjured sides for all parameters. One patient had a nonunion requiring additional operative treatment. The postoperative radiological parameters showed an improvement of radial inclination, radial height, ulnar variance, dorsal tilt, and dorsal tilt. Conclusion Corrective osteotomy for children is an effective method for treating symptomatic malunions of the distal radius. Level of Evidence This is a Level IV study.

Detecting scaphoid fractures in wrist injury: a clinical decision rule.

INTRODUCTION: The aim of this study was to develop and validate an easy to use clinical decision rule, applicable in the ED that limits the number of unnecessary cast immobilizations and diagnostic follow-up in suspected scaphoid injury, without increasing the risk of missing fractures. METHODS: A prospective multicenter study was conducted that consisted of three components: (1) derivation of a clinical prediction model for detecting scaphoid fractures in adult patients following wrist trauma; (2) internal validation of the model; (3) design of a clinical decision rule. The predictors used were: sex, age, swelling of the anatomic snuffbox, tenderness in the anatomic snuffbox, scaphoid tubercle tenderness, painful ulnar deviation and painful axial thumb compression. The outcome measure was the presence of a scaphoid fracture, diagnosed on either initial radiographs or during re-evaluation after 1-2 weeks or on additional imaging (radiographs/MRI/CT). After multivariate logistic regression analysis and bootstrapping, the regression coefficient for each significant predictor was calculated. The effect of the rule was determined by calculating the number of missed scaphoid fractures and reduction of suspected fractures that required a cast. RESULTS: A consecutive series of 893 patients with acute wrist injury was included. Sixty-eight patients (7.6%) were diagnosed with a scaphoid fracture. The final prediction rule incorporated sex, swelling of the anatomic snuffbox, tenderness in the anatomic snuffbox, painful ulnar deviation and painful axial thumb compression. Internal validation of the prediction rule showed a sensitivity of 97% and a specificity of 20%. Using this rule, a 15% reduction in unnecessary immobilization and imaging could be achieved with a 50% decreased risk of missing a fracture compared with current clinical practice. CONCLUSIONS: This dataset provided a simple clinical decision rule for scaphoid fractures following acute wrist injury that limits unnecessary immobilization and imaging with a decreased risk of missing a fracture compared to current clinical practice. CLINICAL PREDICTION RULE: 1/(1 + EXP (-(0.649662618 × if man) + (0.51353467826 × if swelling anatomic snuffbox) + (-0.79038263985 × if painful palpation anatomic snuffbox) + (0.57681198857 × if painful ulnar deviation) + (0.66499549728 × if painful thumb compression)-1.685). TRIAL REGISTRATION: Trial register NTR 2544, www.trialregister.nl.

Long-Term Functional Results of a Wrist Exercise Program for Patients with Palmar Midcarpal Instability.

Background Patients with palmar midcarpal instability have symptoms of pain, combined with clinical signs of abnormal mobility on stressing the joint, an unpredictable blockade feeling, and a noticeable clunk, in the absence of an underlying trauma. No data are available on the effect of conservative treatment for these patients. Purpose The purpose of this study was to evaluate the effect and the long-term functional outcomes of a wrist exercise program in patients with palmar midcarpal instability. Patients and Methods All patients diagnosed with palmar midcarpal instability between 2005 and 2011 were included. Patients completed the Patient-Rated Wrist and Hand Evaluation (PRWHE) and the Short Form-36 health (SF-36) questionnaires, scaled their perceived pain before and after treatment, and indicated the effect of the received treatment. Results A total of 119 patients diagnosed with palmar midcarpal instability were included. The median follow-up time was 6 years (IQR 4.5-7.0). The median PRWHE score after hand therapy was 35.5 and the median mental component of the SF-36 score was 53.9 and the physical component was 45.2. The median perceived pain reduced from eight to four and the median therapeutic effect of the wrist exercise program was five. Conclusion Although palmar midcarpal instability remains to be a chronic disease, the effectiveness of our wrist exercise program is promising with acceptable long-term functional results and a good quality of life. Level of Evidence Level IV, retrospective cohort study.

Three-dimensional virtual planning of corrective osteotomies of distal radius malunions: a systematic review and meta-analysis.

The purpose of this study was to summarize and evaluate results of three-dimensional (3D-) planned corrective osteotomies of malunited distal radius fractures. 3D-planning techniques provide the possibility to address 3D-deformity that conventional planning methods might not address. We systematically searched PubMed, EMBASE and the Cochrane library for studies that performed a 3D-planned corrective osteotomy on patients with a malunited distal radius fracture. Fifteen studies with a total of 68 patients were included in the analysis. In 96% of cases, the preoperatively present palmar tilt, radial inclination and ulnar variance showed statistically significant improvement postoperatively with restoration to within 5° or 2 mm of their normal values. Mean flexion-extension, pro-supination and grip strength showed statistically significant improvement (p < 0.05). Complications were reported in 11 out of 68 patients (16%). With the current advances in 3D printing technology, 3D-planned corrective osteotomies seem a promising technique in the treatment of complex distal radius malunions. Level of evidence IV Systematic review of case series, Level IV.

Non-operative treatment of displaced distal radius fractures leads to acceptable functional outcomes, however at the expense of 40% subsequent surgeries.

BACKGROUND: Although secondary displacement following closed reduction and plaster immobilisation is high, several guidelines still recommend non-operative treatment for displaced distal radius fractures with an adequate closed reduction. PURPOSE: The purpose of this study was to evaluate functional outcomes, measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire, in non-operative treated patients with displaced distal radius fractures and an adequate closed reduction confirmed on radiograph. MATERIALS AND METHODS: From a retrospective database, we reviewed non-operative treated adult patients with an unilateral displaced distal radius fracture and adequate closed reduction confirmed on radiograph. The primary outcome was the DASH score at 12months. DASH scores were prospectively collected pre-trauma and at three, six and 12months. Secondary outcome was the number of subsequent surgeries due to secondary displacement or a symptomatic malunion, and their possible predictors. Additionally, the difference in DASH scores between patients who were treated due to secondary displacement and asymptomatic malunion was compared. RESULTS: One-hundred and sixteen patients were included. The median age was 62 years and 79% was female. Fractures were classified according to the AO/OTA classification as follows: AO/OTA type A (49%), AO/OTA type B (3%), AO/OTA type C (48%). After 12months the median DASH score was 15. Forty-six (40%) patients underwent subsequent surgery due to a secondary displacement or symptomatic malunion. No significant differences in DASH scores between patients who were treated non-operatively and patients who received subsequent surgery were found. Younger patients were more likely to undergo subsequent surgery. Patients with a symptomatic malunion had significant higher DASH scores compared to patients with secondary displacement. DISCUSSION: Non-operative treatment of displaced distal radius fractures after adequate closed reduction confirmed on radiograph leads to acceptable functional outcomes after 12months, however, at the expense of 40% subsequent surgeries. LEVEL OF EVIDENCE: Level IV, retrospective cohort study.

[Analysis of variation in the surgical treatment of distal radius fracture]. / Aanzienlijke variatie in chirurgische behandeling van distale radiusfractuur.

OBJECTIVE: The optimum treatment of patients with distal radius fracture has not been entirely clarified resulting in possible major variations between hospitals in the number of patients undergoing surgical treatment. The objective of this study was to examine the variation in surgical treatment rates of patients with distal radius fractures across Dutch hospitals. DESIGN: Retrospective study. METHOD: Aggregated data for all patients with a distal radius fracture were obtained for 2012 and 2013 on the basis of reimbursement codes. The surgical rate across hospitals was corrected for several variables using linear regression analysis. RESULTS: We analysed a total of 95,754 reimbursements. The operative rate ranged from 0% to 23%, with a mean of 9.6%. Hospital type, the percentage of females, the percentage of patients over 65, the mean age, average socioeconomic status, and the total number of patients treated explained only 2.6% of the observed differences in operative rate between hospitals in 2012 and 11.6% in 2013. CONCLUSION: Our results suggest that non-scientific factors, such as surgeon's age, background, and local culture, influence therapeutic decisions in patients with distal radius fractures.

Corrective osteotomy is an effective method of treating distal radius malunions with good long-term functional results.

INTRODUCTION: Malunion occurs in approximately 23% of non-operatively treated and 11% of operatively treated distal radius fractures. The decision whether to correct a malunion is primarily based on functional impairment and wrist pain. The purpose of this study was to assess the long-term functional outcomes of corrective osteotomies for symptomatic malunited distal radius fractures. METHODS: All consecutive corrective osteotomies of the distal radius performed in one centre between January 2009 and January 2016 were included. The primary outcome was the functional outcome assessed with the Disability of the Arm, Shoulder and Hand (DASH) and the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcomes were range of motion, grip strength, pain as indicated on the Visual Analogue Scale (VAS) before and after corrective osteotomy, radiological parameters, time to union and complications. Additionally, we aimed to determine if there were any difference in graft versus no graft usage. RESULTS: A total of 48 patients were included. The median age was 54.5 years (IQR 39-66) and 71% was female. The median time to follow-up was 27 months. The median DASH and PRWE score were respectively 10.0 (IQR 5.8-23.3) and 18.5. (6.5-37.0). Except for pronation and supination, range of motion and grip strength of the injured wrist were significantly less compared to the uninjured side. Palmar and dorsal flexion and radial and ulnar deviation of the injured wrist were significantly less compared with the uninjured side. VAS pain scores decreased significantly from 6.5 preoperative to 1.0 postoperative. The median time to union was 23 weeks (IQR 12-29.5). Eighteen patients (38%) had a complication for which additional treatment was required. Except for a significant difference in radial inclination and length after the corrective osteotomy in favour of graft usage, there were no significant differences between graft an no graft usage. CONCLUSIONS: Corrective osteotomy is an effective method of treating symptomatic distal radius malunions with good long-term functional results, measured with the DASH and PRWE score, and improvement in radiographic parameters and pain scores. Additionally, no differences in functional outcomes were found between graft and no graft usage.

Classification and treatment of distal radius fractures: a survey among orthopaedic trauma surgeons and residents.

PURPOSE: Classification, the definition of an acceptable reduction and indications for surgery in distal radius fracture management are still subject of debate. The purpose of this study was to characterise current distal radius fracture management in Europe. METHODS: During the European Congress of Trauma and Emergency Surgery (ECTES) 2015 a 20-question multiple-choice survey was conducted among the attending surgeons and residents of the hand and wrist session. Consensus was defined as more than 50 % identical answers (moderate consensus 50-75 % and high consensus more than 75 %). RESULTS: A total of 46 surgeons and residents participated in the survey. High consensus was found among both surgeons and residents for defining the AO/OTA classification as the preferred classification system. For the definition of an acceptable reduction, a moderate to high consensus could be determined. Overall, high consensus was found for non-operative treatment instead of operative treatment in dislocated extra- and intra-articular distal radius fractures with an acceptable closed reduction, regardless of age. We found high (surgeons) and moderate (residents) consensus on the statement that an intra-articular gap or step-off ≥2 mm, in patients younger than 65 years, is an absolute indication for ORIF. The same applied for ORIF in dislocated fractures without an acceptable closed reduction in patients younger than 75 years of age. CONCLUSION: Current distal radius fracture management in Europe is characterised by a moderate to high consensus on the majority of aspects of fracture management.

Minimally invasive stabilization of the distal radioulnar joint: a cadaveric study.

This study describes a minimally invasive procedure for stabilization of the distal radioulnar joint, using a suture-button construct placed percutaneously in the direction of the distal oblique bundle in the distal interosseous membrane. In five cadaveric specimens, placement of the suture-button suspension system reduced dorsal displacement of the radius in an unstable distal radioulnar joint to baseline values, both in neutral position and in pronation and supination. These results indicate the possibility of minimally invasive treatment for distal radioulnar joint instability.

Analysis of variation in the surgical treatment of patients with distal radial fractures in the Netherlands.

The purpose of this study was to examine the variation in surgical treatment rates of patients with distal radius fractures across Dutch hospitals. We obtained all reimbursement data for the treatment of distal radius fractures for 2012 and 2013 categorized by hospital. The surgical rate across hospitals was corrected for possible explanatory variables using linear regression analyses. We analysed a total of 95,754 reimbursements. The operative rate ranged from 0% to 23%, with a mean of 9.6%. Hospital type, the percentage of females, the percentage of patients over 65, the mean age, average socioeconomic status and the total number of patients treated explained only 2.6% of the observed differences in the operative rate among hospitals in 2012 and 11.6% in 2013. Our results suggest that subjective factors, such as surgeon's opinions and preferences, significantly influence therapeutic decisions in patients with distal radius fractures. LEVEL OF EVIDENCE: III.

Predictors of unstable distal radius fractures: a systematic review and meta-analysis.

UNLABELLED: The aim of this study was to perform a systematic review in order to identify predictors of secondary displacement in distal radius fractures. We performed a systematic review and identified all studies that reported secondary displacement following distal radius fractures. Where possible, we pooled the odds ratios of predictors. The initial search yielded 3178 studies of which 27 were included. Multiple studies found that age, shortening, volar comminution, loss of radial inclination, the presence of a volar hook, AO type 3 fractures (A3, B3, C3) and the Older classification were significant predictors of secondary displacement. Pooling revealed a significantly increased risk of secondary displacement in fractures with dorsal comminution, in women and in patients aged >60 years. An associated ulna fracture or intra-articular involvement does not result in an increased risk of secondary displacement. The overview provided in this study can help surgeons to inform patients of the chances of success of closed treatment regarding the radiological outcome and facilitate shared decision making. LEVEL OF EVIDENCE: II.

C21ORF105, A chromosome 21-encoded mRNA, is not a discriminative marker gene for prediction of Down syndrome in maternal plasma.

OBJECTIVES: The presence and detectability of placental mRNA in maternal plasma opens possibilities for the development of non-invasive prenatal diagnostic tests. In this study, we tested C21orf105, a chromosome 21-encoded, placentally expressed gene, in maternal plasma of women carrying a fetus with or without trisomy 21. METHODS: Using real-time RT-PCR, we determined transcript levels of target (C21orf105) and reference (hPL) genes in first-trimester plasma samples. Plasma was obtained from first-trimester EDTA blood after two sequential centrifugation steps and stored at -70 degrees C. After RNA extraction, quantitative RT-PCR was performed using Taqman probes. RESULTS: From the 51 samples, 43 samples were conclusive. Comparison of transcript levels of C21orf105 in both groups showed no significant differences. When expressed as ratios of hPL/C21orf105, the differences between trisomy 21 and normal pregnancies remained non-significant. CONCLUSIONS: The amount of C21orf105 mRNA in maternal plasma, although situated in the Down syndrome critical region on chromosome 21 and up regulated in trisomy 21 placentas, is not higher in women carrying a fetus with trisomy 21.