Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design.

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Effects of anticoagulants on outcome of femoral neck fracture surgery.

PURPOSE: To review records of 330 patients who underwent surgery for femoral neck fractures with or without preoperative anticoagulation therapy. METHODS: Medical records of 235 women and 95 men aged 48 to 103 years (mean, 81.6; standard deviation [SD], 13.1) who underwent surgery for femoral neck fractures with or without preoperative anticoagulation therapy were reviewed. 30 patients were on warfarin, 105 on aspirin, 28 on clopidogrel, and 167 were controls. The latter 3 groups were combined as the non-warfarin group and compared with the warfarin group. Hospital mortality, time from admission to surgery, length of hospital stay, return to theatre, and postoperative complications (wound infection, deep vein thrombosis, and pulmonary embolism) were assessed. RESULTS: The warfarin and control groups were significantly younger than the clopidogrel and aspirin groups (80.8 vs. 80.0 vs. 84.2 vs. 83.7 years, respectively, p<0.05). 81% of the patients underwent surgery within 48 hours of admission. The overall mean time from admission to surgery was 1.8 days; it was longer in the warfarin than the aspirin, clopidogrel, and control groups (3.3 vs. 1.8 vs. 1.6 vs. 1.6 days, respectively, p<0.001). The mean length of hospital stay was 17.5 (SD, 9.6; range, 3-54) days. The overall hospital mortality was 3.9%; it was 6.7% in the warfarin group, 3.8% in the aspirin group, 3.6% in the clopidogrel group, and 3.6% in the control group (p=0.80). Four patients returned to theatre for surgery: one in the warfarin group for washout of a haematoma, 2 in the aspirin group for repositioning of a mal-fixation and for debridement of wound infection, and one in the control group for debridement of wound infection. The warfarin group did not differ significantly from non-warfarin group in terms of postoperative complication rate (6.7% vs. 2.7%, p=0.228) and the rate of return to theatre (3.3% vs. 1%, p=0.318). CONCLUSION: It is safe to continue aspirin and clopidogrel prior to surgical treatment for femoral neck fracture. The risk of delaying surgery outweighs the peri-operative bleeding risk.

Can larger-bodied cemented femoral components reduce periprosthetic fractures? A biomechanical study.

INTRODUCTION: The risk for late periprosthetic femoral fractures is higher in patients treated for a neck of femur fracture compared to osteoarthritis. It has been hypothesised that osteopaenia and consequent decreased stiffness of the proximal femur are responsible for this. We investigated whether a femoral component with a bigger body would increase the torque to failure in a biaxially loaded composite Sawbone model. MATERIALS AND METHODS: A biomechanical bone analogue was used. Two different body sizes (Exeter 44-1 versus 44-4) of a polished tapered cemented femoral stem were implanted by an experienced surgeon in seven bone analogues each and internally rotated at 40°/s until failure. Torque to fracture and fracture energy were measured using a biaxial materials testing device (Instron 8874, MI, USA). The data were non-parametric and therefore tested with the Mann-Whitney U test. RESULTS: The median torque to fracture was 156.7 Nm (IQR 19.7) for the 44-1 stem and 237.1 Nm (IQR 52.9) for the 44-4 stem (p = 0.001). The median fracture energy was 8.5 J (IQR 7.3) for the 44-1 stem and 19.5 J (IQR 8.8) for the 44-4 stem (p = 0.014). CONCLUSION: The use of large body polished tapered cemented stems for neck of femur fractures increases the torque to failure in a biomechanical model and therefore is likely to reduce late periprosthetic fracture risk in this vulnerable cohort.

Hospital mortality after arthroplasty using a cemented stem for displaced femoral neck fractures.

PURPOSE: To review hospital mortality after hemiarthroplasty or total hip arthroplasty (THA) using a cemented stem for displaced femoral neck fractures. METHODS: Medical records of 284 hips in 70 men and 209 women aged 45 to 106 (mean, 81.3) years who underwent hemiarthroplasty (n=232) or THA (n=52) with a cemented stem using third-generation cementing techniques (including use of a plug, lavage, and cement pressurisation) for displaced femoral neck fractures were retrospectively reviewed. According to the American Society of Anesthesiologists (ASA) grading, 6 patients were classified preoperatively as grade 1, 77 as grade 2, 148 as grade 3, 47 as grade 4, and one as grade 5. Patients were operated on within 48 hours. Patients were rehabilitated in the hospital until discharge. The primary outcome measure was hospital mortality, including the cause of death. RESULTS: The mean length of hospital stay was 9.2 (standard deviation, 4.1) days. The hospital mortality was 5.7% (n=16). Of the 16 patients who died, 3 were classified preoperatively as ASA grade 2, 6 as grade 3, and 7 as grade 4. One patient died during the operation. One patient died in the recovery room within 6 hours. Both died from a cardiac arrest and were classified as ASA grade 4. Six patients died within the first 5 days. The causes of death were aspiration pneumonia (n=5), cardiac arrest (n=3), bowel perforation (n=2), multiple organ failure (n=3), type 2 respiratory failure (n=1), heart failure (n=1), and subarachnoid bleeding after a hospital fall (n=1). CONCLUSION: Hemiarthroplasty or THA using a cemented stem resulted in low hospital mortality in our hospital dedicated to the treatment of geriatric hip fractures. Hospital mortality was higher in patients with ASA grade 3 or higher.

Periprosthetic fracture torque for short versus standard cemented hip stems: an experimental in vitro study.

In an attempt to preserve proximal femoral bone stock and achieve a better fit in smaller femora, especially in the Asian population, several new shorter stem designs have become available. We investigated the torque to periprosthetic femoral fracture of the Exeter short stem compared with the conventional length Exeter stem in a Sawbone model. Forty-two stems; 21 shorter and 21 conventional stems both with three different offsets were cemented in a composite Sawbone model and torqued to fracture. Results showed that Sawbone femurs break at a statistically significantly lower torque to failure with a shorter compared to conventional-length Exeter stem of the same offset. Both standard and short-stem designs are safe to use as the torque to failure is 7-10 times that seen in activities of daily living.

Improving maximum flexion with a posterior cruciate retaining total knee arthroplasty: a fluoroscopic study.

Achieving a large range of motion (ROM) is a much-desired clinical outcome after total knee arthroplasty (TKA), especially in Asian and Middle Eastern cultures. TKA design plays an important role in providing the post-operative ROM. This study investigated the kinematics of a new high-flexion posterior cruciate ligament retaining total knee replacement, featuring an enlarged posterior condylar offset and a more conforming tibiofemoral articulation. Two flexion activities were compared to determine which provides higher flexion kinematics. Sixteen North American patients with 20 total knee implants were studied using fluoroscopy and shape matching techniques. Maximum skeletal flexion during a lunge activity averaged 120 degrees +/- 11 degrees, with 11 degrees +/- 4 degrees tibial internal rotation. Kneeling activities showed 11 degrees greater average maximum skeletal flexion (131 degrees +/- 13 degrees, p < 0.05) and 1 degrees less tibial internal rotation (10 degrees +/- 4 degrees, p > 0.05) than lunge activities. We conclude that specific knee implant design features can facilitate high flexion in fixed-bearing cruciate retaining TKA, and that kneeling activities provide higher flexion than lunge activities.