IMPORTANCE Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence... Show moreIMPORTANCE Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. OBJECTIVE To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. DESIGN, SETTING, AND PARTICIPANTS This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. EXPOSURE Hemiarthroplasty using PLA or DLA. MAIN OUTCOME AND MEASURES The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. RESULTS A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31(95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. CONCLUSIONS AND RELEVANCE This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04438226 Show less
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... Show moreIntroduction: 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 dosed 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. Show less
Objectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is... Show moreObjectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is clinically relevant for surgeon and patient to anticipate unplanned secondary procedures, other than operations that can be readily expected such as reconstructive procedures for soft tissue defects. Therefore, the objective of this study was to develop a machine learning (ML) prediction model using the SPRINT data that can give individual patients and their care team an estimate of their particular probability of an unplanned second surgery. Methods: Patients from the SPRINT trial with unilateral TSFs were randomly divided into a training set (80%) and test set (20%). Five ML algorithms were trained in recognizing patterns associated with subsequent surgery in the training set based on a subset of variables identified by random forest algorithms. Performance of each ML algorithm was evaluated and compared based on (1) area under the ROC curve, (2) calibration slope and intercept, and (3) the Brier score. Results: Total data set comprised 1198 patients, of whom 214 patients (18%) underwent subsequent surgery. Seven variables were used to train ML algorithms: (1) Gustilo-Anderson classification, (2) Tscherne classification, (3) fracture location, (4) fracture gap, (5) polytrauma, (6) injury mechanism, and (7) OTA/AO classification. The best-performing ML algorithm had an area under the ROC curve, calibration slope, calibration intercept, and the Brier score of 0.766, 0.954, -0.002, and 0.120 in the training set and 0.773, 0.922, 0, and 0.119 in the test set, respectively. Conclusions: An ML algorithm was developed to predict the probability of subsequent surgery after IMN for TSFs. This ML algorithm may assist surgeons to inform patients about the probability of subsequent surgery and might help to identify patients who need a different perioperative plan or a more intensive approach. Show less
Gerven, P. van; Moumni, M. el; Zuidema, W.P.; Rubinstein, S.M.; Krijnen, P.; Tulder, M.W. van; ... ; Warrior-Trial Study Grp 2019
Background: Routine radiography in the follow-up of distal radial fractures is common practice, although its usefulness is disputed. The aim of this study was to determine whether the number of... Show moreBackground: Routine radiography in the follow-up of distal radial fractures is common practice, although its usefulness is disputed. The aim of this study was to determine whether the number of radiographs in the follow-up period can be reduced without resulting in worse patient outcomes.Methods: In this multicenter, prospective, randomized controlled trial with a non-inferiority design, patients >= 18 years old with a distal radial fracture could participate. They were randomized between a regimen with routine radiographs at 6 and 12 weeks of follow-up (usual care) and a regimen without routine radiographs at those time points (reduced imaging). Randomization was performed using an online registration and randomization program. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score. Secondary outcomes included the Patient-Rated Wrist/Hand Evaluation (PRWHE) score, health-related quality of life, pain, and complications. Outcomes were assessed at baseline and after 6 weeks, 3 months, 6 months, and 1 year of follow-up. Data were analyzed using mixed models. Neither the patients nor the health-care providers were blinded.Results: Three hundred and eighty-six patients were randomized, and 326 of them were ultimately included in the analysis. The DASH scores were comparable between the usual-care group (n = 166) and the reduced-imaging group (n = 160) at all time points as well as overall. The adjusted regression coefficient for the DASH scores was 1.5 (95% confidence interval [CI] = -1.8 to 4.8). There was also no difference between the groups with respect to the overall PRWHE score (adjusted regression coefficient, 1.4 [95% CI = -2.4 to 5.2]), quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) (-0.02 [95% CI = -0.05 to 0.01]), pain at rest as measured with a visual analog scale (VAS) (0.1 [95% CI = -0.2 to 0.5]), or pain when moving (0.3 [95% CI = -0.1 to 0.8]). The complication rate was similar in the reduced imaging group (11.3%) and the usual-care group (11.4%). Fewer radiographs were made for the participants in the reduced-imaging group (median, 3 versus 4; p < 0.05).Conclusions: This study shows that omitting routine radiography after the initial 2 weeks of follow-up for patients with a distal radial fracture does not affect patient-reported outcomes or the risk of complications compared with usual care. Show less
Dijkink, S.; Krijnen, P.; Hage, A.; Wilden, G.M. van der; Kasotakis, G.; Hartog, D. den; ... ; Schipper, I.B. 2019
