Adding Behaviour-Change Counselling to an Exercise Program for Adults Preparing for Hip and Knee Arthroplasty Improves Psychological and Physical Wellness: Focus Group Reflections.

PURPOSE: To explore participant experiences for people on an arthroplasty waitlist, randomised to an exercise and behaviour-change counselling program (ENHANCE). The ENHANCE program for arthroplasty patients was led by an accredited exercise physiologist who delivered an individually tailored and structured exercise program. Included in the exercise program were up to five in-person counselling sessions, based on the Health Action Process Approach (HAPA) applied specifically to people with osteoarthritis. Nine adults (mean 69.4 years) who were on the waiting list for a total hip or knee arthroplasty and who had completed a 12-week program (ENHANCE) as part of a randomised controlled trial were recruited for this study. METHODS: Two focus groups were conducted to explore participant experiences of ENHANCE. Data were analysed using inductive thematic analysis with constructs of the HAPA (motivational and volitional factors) as a framework. RESULTS: We identified three themes (1) 'The structured program addressed inactivity and improved feelings of wellness and preparation for the operation'. The benefits were not only physical, but psychological and were contextualised in terms of preparation for the upcoming surgery. (2) 'People as enablers of participation': Participants identified that the attitude, and skill of the experienced instructor were supportive and motivating, especially in tailoring the intervention. Within the program, the support of the group was considered a positive attribute (3) 'Improved awareness changed attitudes to self-efficacy and perceived self-control'. Participants described an increased awareness of their condition and a better understanding of health expectations. They felt more control and ownership over their health journey. CONCLUSION: Goal setting and social support were identified factors in a behaviour-change counselling program, delivered in conjunction with structured exercise that led to a positive experience. Improved psychological and physical health were described. Participants were better prepared for their upcoming surgery, with increased self efficacy and mastery to support long-term physical-activity engagement.

Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty.

BACKGROUND: The addition of vancomycin to beta-lactam prophylaxis in arthroplasty may reduce surgical-site infections; however, the efficacy and safety are unclear. METHODS: In this multicenter, double-blind, superiority, placebo-controlled trial, we randomly assigned adult patients without known methicillin-resistant Staphylococcus aureus (MRSA) colonization who were undergoing arthroplasty to receive 1.5 g of vancomycin or normal saline placebo, in addition to cefazolin prophylaxis. The primary outcome was surgical-site infection within 90 days after surgery. RESULTS: A total of 4239 patients underwent randomization. Among 4113 patients in the modified intention-to-treat population (2233 undergoing knee arthroplasty, 1850 undergoing hip arthroplasty, and 30 undergoing shoulder arthroplasty), surgical-site infections occurred in 91 of 2044 patients (4.5%) in the vancomycin group and in 72 of 2069 patients (3.5%) in the placebo group (relative risk, 1.28; 95% confidence interval [CI], 0.94 to 1.73; P = 0.11). Among patients undergoing knee arthroplasty, surgical-site infections occurred in 63 of 1109 patients (5.7%) in the vancomyin group and in 42 of 1124 patients (3.7%) in the placebo group (relative risk, 1.52; 95% CI, 1.04 to 2.23). Among patients undergoing hip arthroplasty, surgical-site infections occurred in 28 of 920 patients (3.0%) in the vancomyin group and in 29 of 930 patients (3.1%) in the placebo group (relative risk, 0.98; 95% CI, 0.59 to 1.63). Adverse events occurred in 35 of 2010 patients (1.7%) in the vancomycin group and in 35 of 2030 patients (1.7%) in the placebo group, including hypersensitivity reactions in 24 of 2010 patients (1.2%) and 11 of 2030 patients (0.5%), respectively (relative risk, 2.20; 95% CI, 1.08 to 4.49), and acute kidney injury in 42 of 2010 patients (2.1%) and 74 of 2030 patients (3.6%), respectively (relative risk, 0.57; 95% CI, 0.39 to 0.83). CONCLUSIONS: The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty among patients without known MRSA colonization. (Funded by the Australian National Health and Medical Research Council; Australian New Zealand Clinical Trials Registry number, ACTRN12618000642280.).

Effect of Aspirin vs Enoxaparin on 90-Day Mortality in Patients Undergoing Hip or Knee Arthroplasty: A Secondary Analysis of the CRISTAL Cluster Randomized Trial.

Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.

The association between body mass index and patient-reported outcome measures before and after primary total hip or knee arthroplasty: a registry.

BACKGROUND: The objective is to determine whether body mass index is associated with patient-reported expectations and well-being before primary total hip or total knee arthroplasty, and patient-reported outcomes 6 months after surgery. METHODS: Data were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Outcome measures included pre-operative expectations for post-operative mobility, joint pain and health, pre- and post-operative EQ-5D-5L, EQ-VAS, Oxford Hip/Knee Scores and joint pain scales, and post-operative perceived change and perceived satisfaction. Associations with BMI were assessed using chi-square tests, analysis of variance and Linear Mixed Models equations. RESULTS: Data were available for 12 816 primary THA patients and 20 253 primary TKA patients. Pre-operatively, patients in higher BMI categories were significantly more likely to expect ongoing problems with mobility, more joint pain and poorer health following surgery (P<0.01 for all analyses). For arthroplasty patients, higher BMI was associated with poorer pre-operative and post-operative scores for all measures. BMI was positively associated with improvements in EQ-5D, OHS/KS and joint pain. While between-group differences were statistically significant, many were small in magnitude. There was no association between BMI and patient-perceived change or satisfaction after arthroplasty. CONCLUSION: Patients undergoing THA/TKA, higher BMI was associated with lower pre-operative expectations, poorer well-being before surgery, and worse scores after surgery. Patients who were obese demonstrated comparable satisfaction with their operated joint, compared with non-obese patients. BMI was associated with greater pre- to post-operative improvements in outcome scores for EQ-5D, VAS knee, OHS/OKS and joint pain but these differences may not be clinically important.

Perception of Perioperative Risk for Arthroplasty Patients: A Poll of Australian Orthopedic Surgeons.

BACKGROUND: There is growing interest in the perioperative management of patients who have indications for hip and knee arthroplasty in the setting of modifiable risk factors such as morbid obesity, poorly controlled diabetes, and smoking. A recent survey of the American Association of Hip and Knee Surgeons (AAHKS) found that 95% of respondents address modifiable risk factors prior to surgery. The aim of this study was to poll Australian arthroplasty surgeons regarding their approach to patients who have modifiable risk factors. METHODS: The survey tool used in the AAHKS study was adapted for use in the Australian context and distributed to the membership of the Arthroplasty Society of Australia via SurveyMonkey. There were 77 responses received, representing a response rate of 64%. RESULTS: The majority of respondents were experienced, high volume arthroplasty surgeons. Overall, 91% of respondents restricted access to arthroplasty for patients who have modifiable risk factors. There were 72% restricting access for excessive body mass index, 85% for poor diabetic control, and 46% for smoking. Most respondents made decisions based on personal experience or literature review rather than hospital or departmental pressures. While 49% of surgeons believed that current payment systems did not impair their ability to achieve good outcomes, 58% believed that certain arthroplasty patients would benefit from additional intervention, based on their socioeconomic status. CONCLUSION: Over 90% of surgeons who responded address modifiable risk factors prior to surgery. This finding aligns with the practice patterns of AAHKS members, despite differences in healthcare systems.

Introduction to surgical coaching.

Surgical coaching is a new approach to continuous professional development (CPD). Advocates claim that coaching improves surgical and non-technical skills, leading to enhanced performance and reduced stress and burnout. Widespread acceptance of coaching in the surgical community is limited due to a paucity of evidence, surgery-specific obstacles and lack of resources. This narrative review introduces what 'surgical coaching' is and describes its origins. Coaching techniques are based on live or video observation of procedures, followed by collaborative analysis, reflection and goal planning in a non-competitive setting aided by an expert, peer or lay coach. Technical skills improvements have been reported using coaching techniques, yet long-term influence on non-technical competencies, overall performance and surgeon wellbeing are largely hypothetical. There are clear potential benefits in the application of surgical coaching to daily surgical practice. However, significant knowledge gaps remain. Dedicated research into the short-term applicability and the long-term effects of surgical coaching are required.

Effect of combined exercise training and behaviour change counselling versus usual care on physical activity in patients awaiting hip and knee arthroplasty: A randomised controlled trial.

Objective: This study aimed to determine if a novel intervention that combined individualised exercise training with behaviour change counselling based on Health Action Process Approach (HAPA) constructs could elicit long-term increase in physical activity (PA) and reduce comorbidity development among people requiring hip or knee arthroplasty. Method: A pre-registered two arm, parallel group, randomised controlled trial comparing the effect of a 12-week individualised exercise program combined with behavioural counselling delivered by accredited exercise physiologists, versus usual care to Osteoarthritis (OA) patients on public surgery waitlists. Participants were followed up at 6 months after baseline (pre-surgery) and again at 6 months post-surgery. Within and between group differences in post-surgery PA (as measured by ActivPal accelerometer), pain, function, quality of life, HAPA-based behavioural and psychological constructs, and health risk factors were analysed. Results: 63 participants (34 Female; Mean age â€‹= â€‹66.4 â€‹± â€‹7.2 â€‹yrs) consented to participate in this study. At 6 months post baseline and 6 months post-surgery there were significant improvements in PA, pain, function, and quality of life, however there were no significant differences in the between group responses. Significant between group changes were observed in several psychological constructs related to volition at 6 months post baseline; however, these had disappeared by 6 months post-surgery. Conclusions: An exercise program and HAPA guided counselling intervention can improve psychological constructs related to exercise behaviour; however, these did not result in significant between group changes in PA at the timepoints measured. Further research with larger sample size is required.Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN 12617000357358) Date of registration: 08/03/2017.

A desirability of outcome ranking (DOOR) for periprosthetic joint infection - a Delphi analysis.

Background: Treatment outcomes in studies on prosthetic joint infection are generally assessed using a dichotomous outcome relating to treatment success or failure. These outcome measures neither include patient-centred outcome measures including joint function and quality of life, nor do they account for adverse effects of treatment. A desirability of outcome ranking (DOOR) measure can include these factors and has previously been proposed and validated for other serious infections. We aimed to develop a novel DOOR for prosthetic joint infections (PJIs). Methods: The Delphi method was used to develop a DOOR for PJI research. An international working group of 18 clinicians (orthopaedic surgeons and infectious disease specialists) completed the Delphi process. The final DOOR comprised the dimensions established to be most important by consensus with > 75  % of participant agreement. Results: The consensus DOOR comprised four main dimensions. The primary dimension was patient-reported joint function. The secondary dimensions were infection cure and mortality. The final dimension of quality of life was selected as a tie-breaker. Discussion: A desirability of outcome ranking for periprosthetic joint infection has been proposed. It focuses on patient-centric outcome measures of joint function, cure and quality of life. This DOOR provides a multidimensional assessment to comprehensively rank outcomes when comparing treatments for prosthetic joint infection.

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial.

Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA. Design, Setting, and Participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021. Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation. Main Outcomes and Measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group. Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group. Conclusions and Relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis. Trial Registration: ANZCTR Identifier: ACTRN12618001879257.

Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Distal radius fractures are common and are managed with or without surgery. Current evidence indicates surgical treatment is not superior to nonsurgical treatment at 12 months. Objective: Does surgical treatment for displaced distal radius fractures in patients 60 years or older provide better patient-reported wrist pain and function outcomes than nonsurgical treatment at 24 months? Design, Setting, and Participants: In this secondary analysis of a combined multicenter randomized clinical trial (RCT) and a parallel observational study, 300 patients were screened from 19 centers in Australia and New Zealand. Of these, 166 participants were randomized to surgical or nonsurgical treatment. Participants who declined randomization (n = 134) were included in the parallel observational group with the same treatment options and follow-up. Participants were followed up at 3, 12, and 24 months by a blinded assessor. The 24-month outcomes are reported herein. Data were collected from December 1, 2016, to December 31, 2020, and analyzed from February 4 to October 21, 2021. Interventions: Surgical treatment consisting of open reduction and internal fixation using a volar-locking plate (VLP group) and nonsurgical treatment consisting of closed reduction and cast immobilization (CR group). Main Outcomes and Measures: The primary outcome was patient-reported function using the Patient-Rated Wrist Evaluation (PRWE) questionnaire. Secondary outcomes included health-related quality of life, wrist pain, patient-reported treatment success, patient-rated bother with appearance, and posttreatment complications. Results: Among the 166 randomized and 134 observational participants (300 participants; mean [SD] age, 71.2 [7.5] years; 269 women [89.7%]), 151 (91.0%) randomized and 118 (88.1%) observational participants were followed up at 24 months. In the RCT, no clinically important difference occurred in mean PRWE scores at 24 months (13.6 [95% CI, 9.1-18.1] points for VLP fixation vs 15.8 [95% CI, 11.3-20.2] points for CR; mean difference, 2.1 [95% CI, -4.2 to 8.5]; P = .50). There were no between-group differences in all other outcomes except for patient-reported treatment success, which favored VLP fixation (33 of 74 [44.6%] in the CR group vs 54 of 72 [75.0%] in the VLP fixation group reported very successful treatment; P = .002). Rates of posttreatment complications were generally low and similar between treatment groups, including deep infection (1 of 76 [1.3%] in the CR group vs 0 of 75 in the VLP fixation group) and complex regional pain syndrome (2 of 76 [2.6%] in the CR group vs 1 of 75 [1.3%] in the VLP fixation group). The 24-month trial outcomes were consistent with 12-month outcomes and with outcomes from the observational group. Conclusions and Relevance: Consistent with previous reports, these findings suggest that VLP fixation may not be superior to CR for displaced distal radius fractures for patient-rated wrist function in persons 60 years or older during a 2-year period. Significantly higher patient-reported treatment success at 2 years in the VLP group may be attributable to other treatment outcomes not captured in this study. Trial Registration: ANZCTR.org Identifier: ACTRN12616000969460.

Periprosthetic fracture as a late mode of failure of the Anatomique Benoist Girard II femoral prosthesis.

AIM: The Anatomique Benoist Girard (ABG) II femoral implant was a commonly used stem for primary total hip replacement (THR) at our institution (Launceston, Tasmania Australia). We identified peri-prosthetic fracture as the main cause of late failure. METHODS: The late periprosthetic fracture rate for ABG II implants was reviewed with national statistics, using Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data. National revision rates for periprosthetic fracture were used to compare ABG II with all other cementless femoral stems. RESULT: ABG II stems accounted for 1% (2719 implants) of all femoral stem implants in Australia during the 12-year review period, compared to 23% (587 implants) in Launceston Hospitals. Although the Launceston cumulative percent revision rate for the ABG II stem was lower than the National rate at all time points, the reasons for revision were similar. The most common reason for revision of ABG II was fracture (56.8%), followed by loosening (15.3%). This differs from the reasons for revision in other cementless prostheses (loosening 23.9%, fracture 20.8%, dislocation 18.7%). Cumulative percent revision rates from late periprosthetic fracture, were higher for the ABG II stem than other cementless femoral prostheses. CONCLUSION: This review of the AOANJRR has confirmed a local and national higher revision rate of the ABG II stem due to late periprosthetic fracture compared with other cementless stems. Stem design must be considered to reduce the risk of late periprosthetic fracture.

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial.

Importance: The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence. Objective: To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older. Design, Setting, and Participants: In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses. Intervention: Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR). Main Outcomes and Measures: The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use. Results: In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI -5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02). Conclusions and Relevance: This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people. Trial Registration: http://anzctr.org.au identifier: ACTRN12616000969460.

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan.

BACKGROUND: We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. METHODS/DESIGN: A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. DISCUSSION: This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. TRIAL REGISTRATION: CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.

Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.

INTRODUCTION: Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The primary hypothesis of this study is that achieving knee balance with use of sensors in TKA will improve patient-reported outcomes when compared with manual balancing. METHODS AND ANALYSIS: A multicentred, randomised controlled trial will compare patient-reported outcomes in 222 patients undergoing TKA using sensor-guided balancing versus manual balancing. The sensor will be used in both arms for purposes of data collection; however, surgeons will be blinded to the pressure data in patients randomised to manual balancing. The primary outcome will be the change from baseline to 1 year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life. Secondary outcomes will include the surgeon's capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes. Normality of data will be assessed, and a Student's t-test and equivalent non-parametric tests will be used to compare differences in means among the two groups. ETHICS AND DISSEMINATION: Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320). Results of the trial will be presented at orthopaedic surgical meetings and submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ACTRN#12618000817246.

Diagnosis and management of chronic hip and knee pain in a Tasmanian orthopaedic clinic: a study assessing the diagnostic and treatment planning decisions of an advanced scope physiotherapist.

The aim of this study is to investigate the clinical effectiveness of an advanced practice physiotherapist triaging patients referred from primary care to the orthopaedic clinic with chronic hip and knee pain. An exploratory study design was used to assess 87 consecutive patients referred from general practice in Northern Tasmania. Patients were assessed by both an advanced practice physiotherapist and a consultant orthopaedic surgeon. Diagnostic and treatment decisions were compared, with the orthopaedic consultant decision defined as the gold standard. By using these decisions, over and under referral rates to orthopaedics could be calculated, as well as the surgical conversion rate. Conservative care of patients referred to the orthopaedic clinic with hip and knee pain was limited. The diagnostic agreement between the advanced scope physiotherapist and the orthopaedic surgeon was almost perfect (weighted kappa 0.93 (95% CI 0.87-1.00)), with treatment agreement substantial (weighted kappa 0.75 (95% CI 0.62-0.89)). Under a physiotherapist-led triage service, the surgical conversion rate doubled from 38% to 78%. An advanced physiotherapist assessing and treating patients with chronic hip and knee pain made decisions that match substantially with decisions made by an orthopaedic consultant. A model of care utilising an advanced physiotherapist in this way has the potential to support high-quality orthopaedic care in regional centres.

Does Dexamethasone Reduce Hospital Readiness for Discharge, Pain, Nausea, and Early Patient Satisfaction in Hip and Knee Arthroplasty? A Randomized, Controlled Trial.

BACKGROUND: Reduction in postoperative pain, nausea, and vomiting in patients undergoing total joint arthroplasty may facilitate earlier discharge from hospital and reduce healthcare costs. This study was performed to primarily assess whether perioperative dexamethasone reduced hospital length of stay and to assess the effect on pain, nausea and vomiting, and patient satisfaction. METHODS: One hundred sixty-four patients undergoing total hip arthroplasty or total knee arthroplasty were randomized to receive either 8 mg intravenous dexamethasone (n = 86) or placebo (n = 78) at induction and at 24 hours postsurgery. The primary outcome was length of stay and secondary outcomes were pain and nausea visual analog scale scores, analgesic and antiemetic usage, blood glucose level, and patient satisfaction. RESULTS: Participants in the study group achieved earlier readiness for discharge. There was a 20% reduction in pain scores and morphine usage was 27% lower in the study group. Nausea scores were similar in the 2 groups but there was lower antiemetic usage in the study group. Satisfaction scores at 6 weeks postsurgery in the dexamethasone group were significantly higher than the placebo group. There was no difference in complication rates between the 2 groups. CONCLUSION: The administration of intravenous dexamethasone could lead to earlier readiness for discharge especially in patients undergoing elective total hip arthroplasty, primarily by a reduction in postoperative pain scores and/or morphine requirements.

Improving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling: study protocol for a randomised controlled trial.

BACKGROUND: Osteoarthritis often results in prolonged periods of reduced physical activity and is associated with adverse health outcomes, including increased risk of cardiovascular and metabolic diseases. Exercise interventions for patients on the waiting list for arthroplasty can reduce the risk of long-term adverse outcomes by increasing activity levels. However, uptake and ongoing positive rates of physical activity in this population are low and the impact of pre-operative behaviour counselling on exercise is not known. METHOD/DESIGN: The exercise and behaviour change counselling (ENHANCE) trial is a two-arm assessor-blind randomised controlled trial to assess the effectiveness of a 12-week exercise intervention designed to improve long-term physical activity and functional abilities for people awaiting arthroplasty. Participants on the waiting list for hip and knee arthroplasty are recruited from one clinical site in Australia. After collection of baseline data, participants are randomised to either an intervention or control group. The control group receive usual care, as recommended by evidence-based guidelines. The intervention group receive an individualised programme of exercises and counselling sessions. The 12-week exercise programme integrates multiple elements, including up to five in-person counselling sessions, supported by written materials. Participants are encouraged to seek social support among their friends and self-monitor their physical activity. The primary outcome is physical activity (daily step count and percentage of day spent in sedentary activities). Secondary outcomes include pain ratings, physical function, psychosocial factors and changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease). All outcomes are assessed at baseline and 26 weeks later and again at 26 weeks post-surgery. DISCUSSION: This study seeks to address a significant gap in current osteoarthritis management practice by providing evidence for the effectiveness of an exercise programme combined with behaviour counselling for adults waiting for hip and knee arthroplasty. Theory-driven evidence-based strategies that can improve an individual's exercise self-efficacy and self-management capacity could have a significant impact on the development of secondary chronic disease in this population. Information gained from this study will contribute to the evidence base on the management of adults waiting for hip and knee arthroplasty. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000357358 . Registered on 8 March 2017.

A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE)-a study protocol.

Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. METHODS AND ANALYSIS: This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. ETHICS AND DISSEMINATION: CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies. REGISTRATION: CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).