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
Background: Statistical models using machine learning (ML) have the potential for more accurate estimates of the probability of binary events than logistic regression. The present study used... Show moreBackground: Statistical models using machine learning (ML) have the potential for more accurate estimates of the probability of binary events than logistic regression. The present study used existing data sets from large musculoskeletal trauma trials to address the following study questions: (1) Do ML models produce better probability estimates than logistic regression models? (2) Are ML models influenced by different variables than logistic regression models? Methods: We created ML and logistic regression models that estimated the probability of a specific fracture (posterior malleolar involvement in distal spiral tibial shaft and ankle fractures, scaphoid fracture, and distal radial fracture) or adverse event (subsequent surgery [after distal biceps repair or tibial shaft fracture], surgical site infection, and postoperative delirium) using 9 data sets from published musculoskeletal trauma studies. Each data set was split into training (80%) and test (20%) subsets. Fivefold cross-validation of the training set was used to develop the ML models. The best-performing model was then assessed in the independent testing data. Performance was assessed by (1) discrimination (c-statistic), (2) calibration (slope and intercept), and (3) overall performance (Brier score). Results: The mean c-statistic was 0.01 higher for the logistic regression models compared with the best ML models for each data set (range, -0.01 to 0.06). There were fewer variables strongly associated with variation in the ML models, and many were dissimilar from those in the logistic regression models. Conclusions: The observation that ML models produce probability estimates comparable with logistic regression models for binary events in musculoskeletal trauma suggests that their benefit may be limited in this context. Show less
Loon, J. van; Sierevelt, I.N.; Spekenbrink-Spooren, A.; Opdam, K.T.M.; Poolman, R.W.; Kerkhoffs, G.M.M.J.; Haverkamp, D. 2022
Background and purpose: The influence of bearing on short-term revision in press-fit total hip arthroplasty (THA) remains under-reported. The aim of this study was to describe 2-year cup revision... Show moreBackground and purpose: The influence of bearing on short-term revision in press-fit total hip arthroplasty (THA) remains under-reported. The aim of this study was to describe 2-year cup revision rates of ceramic-on-ceramic (CoC) and ceramic-on-polyethylene (CoPE). Patients and methods: Primary press-fit THAs with one of the three most used cups available with both CoC or CoPE bearing recorded in the Dutch Arthroplasty Register (LROI) were included (2007-2019). Primary outcome was 2-year cup revision for all reasons. Secondary outcomes were: reasons for revision, incidence of different revision procedures and use of both bearings over time. Results: 2-year Kaplan-Meier cup revision rate in 33,454 THAs (12,535 CoC; 20,919 CoPE) showed a higher rate in CoC (0.67% [95% CI, 0.54-0.81]) compared to CoPE (0.44% [95% CI, 0.34-0.54]) (p = 0.004). Correction for confounders (age, gender, cup type, head size) resulted in a hazard ratio (HR) of 0.64 [95%CI, 0.48-0.87] (p = 0.019). Reasons for cup revision differed only by more cup revision due to loosening in CoC (26.2% vs.1 3.2%) (p = 0.030). For aseptic loosening a revision rate of 0.153% [95% CI, 0.075-0.231] was seen in CoC and 0.058% [95%CI 0.019-0.097] in CoPE (p = 0.007). Correction for head size resulted in a HR of 0.475 [95% CI, 0.197-1.141] (p = 0.096). Incidence of different revision procedures did not differ between bearings. Over time the use of CoPE has increased and CoC decreased. Conclusions: A higher 2-year cup revision rate in press-fit THA was observed in CoC compared to CoPE. Cup loosening was the only significantly different reason for revision and seen more often in CoC and mostly aseptic. Future randomised controlled trials need to confirm causality, since the early cup revision data provided has the potential to be useful when choosing the bearing in press-fit THA, when combined with other factors like bone quality and patient and implant characteristics. Show less
Loon, J. van; Sierevelt, I.N.; Spekenbrink-Spooren, A.; Opdam, K.T.M.; Poolman, R.W.; Kerkhoffs, G.M.M.J.; Haverkamp, D. 2022
Background and purpose: The influence of bearing on short-term revision in press-fit total hip arthroplasty (THA) remains under-reported. The aim of this study was to describe 2-year cup revision... Show moreBackground and purpose: The influence of bearing on short-term revision in press-fit total hip arthroplasty (THA) remains under-reported. The aim of this study was to describe 2-year cup revision rates of ceramic-on-ceramic (CoC) and ceramic-on-polyethylene (CoPE). Patients and methods: Primary press-fit THAs with one of the three most used cups available with both CoC or CoPE bearing recorded in the Dutch Arthroplasty Register (LROI) were included (2007-2019). Primary outcome was 2-year cup revision for all reasons. Secondary outcomes were: reasons for revision, incidence of different revision procedures and use of both bearings over time. Results: 2-year Kaplan-Meier cup revision rate in 33,454 THAs (12,535 CoC; 20,919 CoPE) showed a higher rate in CoC (0.67% [95% CI, 0.54-0.81]) compared to CoPE (0.44% [95% CI, 0.34-0.54]) (p = 0.004). Correction for confounders (age, gender, cup type, head size) resulted in a hazard ratio (HR) of 0.64 [95%CI, 0.48-0.87] (p = 0.019). Reasons for cup revision differed only by more cup revision due to loosening in CoC (26.2% vs.1 3.2%) (p = 0.030). For aseptic loosening a revision rate of 0.153% [95% CI, 0.075-0.231] was seen in CoC and 0.058% [95%CI 0.019-0.097] in CoPE (p = 0.007). Correction for head size resulted in a HR of 0.475 [95% CI, 0.197-1.141] (p = 0.096). Incidence of different revision procedures did not differ between bearings. Over time the use of CoPE has increased and CoC decreased. Conclusions: A higher 2-year cup revision rate in press-fit THA was observed in CoC compared to CoPE. Cup loosening was the only significantly different reason for revision and seen more often in CoC and mostly aseptic. Future randomised controlled trials need to confirm causality, since the early cup revision data provided has the potential to be useful when choosing the bearing in press-fit THA, when combined with other factors like bone quality and patient and implant characteristics. 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
Zaanen, Y. van; Hoorntje, A.; Koenraadt, K.L.M.; Bodegom-Vos, L. van; Kerkhoffs, G.M.M.J.; Waterval-Witjes, S.; ... ; Kuijer, P.P.F.M. 2020
Background and purpose - Guidelines for managing hip and knee osteoarthritis (OA) advise extensive non-surgical treatment prior to surgery. We evaluated what percentage of hip and knee OA patients... Show moreBackground and purpose - Guidelines for managing hip and knee osteoarthritis (OA) advise extensive non-surgical treatment prior to surgery. We evaluated what percentage of hip and knee OA patients received non-surgical treatment prior to arthroplasty, and assessed patient satisfaction regarding alleviation of symptoms and performance of activities. Patients and methods - A multi-center cross-sectional study was performed in 2018 among 186 patients who were listed for hip or knee arthroplasty or had undergone surgery within the previous 6 months in the Netherlands. Questions concerned non-surgical treatments received according to the Stepped Care Strategy and were compared with utilization in 2013. Additionally, satisfaction with treatment effects for pain, swelling, stiffness, and activities of daily life, work, and sports/leisure was questioned. Results - The questionnaire was completed by 175 patients, age 66 years (range 38-84), 57% female, BMI 29 (IQR 25-33). Step 1 treatments, such as acetaminophen and lifestyle advice, were received by 79% and 60% of patients. Step 2 treatments, like exercise-based therapy and diet therapy, were received by 66% and 19%. Step 3-intra-articular injection-was received by 47%. Non-surgical treatment utilization was lower than in 2013. Nearly all treatments showed more satisfied patients regarding pain relief and fewer regarding activities of work/sports/leisure. Hip and knee OA patients were mostly satisfied with NSAIDs for all outcomes, while exercise-based therapy was rated second best. Interpretation - Despite international guideline recommendations, non-surgical treatment for hip and knee OA remains underutilized in the Netherlands. Of the patients referred for arthroplasty, more were satisfied with the effect of non-surgical treatment on pain than on work/sports/leisure participation. Show less
