Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.

OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.

Delivering surgical education: a specialist surgical society and undergraduate student collaboration.

Currently, the delivery of the undergraduate medical curriculum includes various teaching, learning and assessment strategies. Self-directed learning is an important aspect of this mix and includes the use of resources, sometimes not provided by the parent University, in the student's own time to enhance the student's knowledge, skills and professional practice. Societies aimed at a particular specialty contain a pool of professionals that can provide undergraduate students with opportunities for further self-directed learning, development of specialty-specific core skills and exploration of research interests. This may then enhance and enlighten the students' approach to a particular orthopaedic problem and reinforce the curriculum they are studying while providing an understanding of current areas of debate that are not part of the curriculum at present. The collaboration of postgraduate societies with undergraduate students in developing and implementing undergraduate engagement strategies is of benefit to undergraduate education, the specialty society and the collaborating students. We explore the planning and implementation of an interactive webinar series run by the British Indian Orthopaedic Society in collaboration with undergraduate students. We provide a case study of a surgical specialty society engaging with undergraduate students with synergistic effect. We pay particular attention to the benefits accrued by the specialty society and the student collaborators by this joint effort.

EPOS trial: the effect of air filtration through a plasma chamber on the incidence of surgical site infection in orthopaedic surgery: a study protocol of a randomised, double-blind, placebo-controlled trial.

INTRODUCTION: There is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and by the need for recruiting large enough cohorts. The aim of this study is to investigate whether using a new form of air purifier using plasma air purification (PAP) in operating rooms (ORs) lowers the SSI rate or not. METHODS AND ANALYSIS: Multicentre, double-blind, cluster-randomised, placebo-controlled trial conducted at seven hospitals in 2017-2022. All patients that undergo orthopaedic surgery for minimum 30 min are included. Intervention group: patients operated in OR with PAP devices turned on. CONTROL GROUP: patients operated in OR with PAP devices turned off. Randomisation: each OR will be randomised in periods of 4 weeks, 6 weeks or 8 weeks to either have the devices on or off. PRIMARY OUTCOME: any SSI postoperatively defined as a composite endpoint of any of the following: use of isoxazolylpenicillin, clindamycin or rifampicin for 2 days or more, International Classification of Diseases codes or Nordic Medico-Statistical Committee codes indicating postoperative infection. In a second step, we will perform a chart review on those patients with positive indicators of SSI to further validate the outcome. Secondary outcomes are described in the Methods section. Power: we assume an SSI rate of 2%, an SSI reduction rate of 25% and we need approximately 45 000 patients to attain a power of 80% at a significance level of 0.05. ETHICS AND DISSEMINATION: The study is approved by the Swedish Ethical Review Authority. The interim analysis results from the study will be presented only to the researchers involved unless the study thereafter is interrupted for whatever reason. Publication in a medical journal will be presented after inclusion of the last patient. TRIAL REGISTRATION NUMBER: NCT02695368.

Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol.

INTRODUCTION: More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%-0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications. METHODS AND ANALYSIS: Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board. ETHICS AND DISSEMINATION: The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants. TRIAL REGISTRATION: NCT02810704.

Experience of the COVID-19 pandemic as lived by patients with hip and knee osteoarthritis: an Italian qualitative study.

OBJECTIVE: To examine the experience of the COVID-19 pandemic as lived by people with hip and knee osteoarthritis (OA), in Italy. DESIGN: A qualitative study based on semi-structured interviews. SETTING: Urban and suburban areas in northern Italy. PARTICIPANTS: A total of 11 people with OA were enrolled through a purposeful sampling and completed the study. PRIMARY OUTCOME MEASURE: The experience of Italian people with OA during the COVID-19 pandemic. RESULTS: Four themes were brought to the forefront from the analysis of the interviews. (1) Being Stressed for the Limited Social Interactions and for the Family Members at High Risk of Infection, as the interviewees were frustrated because they could not see their loved ones or felt a sense of apprehension for their relatives. (2) Recurring Strategies to Cope with the Pandemic such as an active acceptance towards the situation. (3) Being Limited in the Possibility of Undergoing OA Complementary Treatments and Other Routine Medical Visits. (4) Being Unaware of the Importance of Physical Activity as First-Line Interventions which was an attitude already present before the pandemic. CONCLUSION: The COVID-19 pandemic and related restrictions impacted the quality of life and the care of individuals with hip and knee OA. The social sphere seemed to be the most hindered. However, the interviewees developed a good level of acceptance to deal with the pandemic. When it came to their care, they faced a delay of routine medical visits not related to OA and of other complementary treatments (eg, physical therapies) to manage OA. Finally, a controversial result that emerged from these interviews was that first-line interventions for OA (ie, therapeutic exercise) was not sought by the interviewees, regardless of the restrictions dictated by the pandemic. Policy-making strategies are thus necessary to support the awareness of the importance of such interventions.