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"Adult orthopaedics"
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Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol
by
Browne, James A
,
Bulger, Roger
,
Mont, Michael A
in
Adult
,
adult orthopaedics
,
anaesthesia in orthopaedics
2022
IntroductionMore 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 analysisPulmonary 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 disseminationThe 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 registrationNCT02810704.
Journal Article
Periprosthetic fractures: the next fragility fracture epidemic? A national observational study
by
Davies, Benjamin M
,
White, Stuart
,
Moppett, Iain
in
adult orthopaedics
,
Aged
,
Aged, 80 and over
2020
ObjectivesPeriprosthetic fractures have considerable clinical implications for patients and financial implications for healthcare systems. This study aims to determine the burden of periprosthetic fractures of the lower and upper limbs in England and identify any factors associated with differences in treatment and outcome.DesignA national, observational study.SettingEngland.ParticipantsAll individuals admitted to hospital with periprosthetic fractures between 1 April 2015 and 31 December 2018.Primary and secondary outcome measuresMortality, length of stay, change in rate of admissions.MethodsWe analysed Hospital Episode Statistics data using the International Classification of Diseases 10th Revision code M96.6 (Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate) to identify periprosthetic fractures recorded between April 2013 and December 2018. We determined the demographics, procedures performed, mortality rates and discharge destinations. Patient characteristics associated with having a procedure during the index admission were estimated using logistic regression. The annual rate of increase in admissions was estimated using Poisson regression.ResultsBetween 1 April 2015 and 31 December 2018, there were 13 565 patients who had 18 888 admissions (89.5% emergency) with M96.6 in the primary diagnosis field. There was a 13% year-on-year increase in admissions for periprosthetic fracture in England during that period. Older people, people living in deprived areas and those with heart failure or neurological disorders were less likely to receive an operation. 14.4% of patients did not return home after hospital discharge. The overall inpatient mortality was 4.3% and total 30-day mortality was 3.3%.ConclusionsThe clinical and operational burden of periprosthetic fractures is considerable and increasing rapidly. We suggest that the management of people with periprosthetic fractures should be undertaken and funded in a similar manner to that successfully employed for people sustaining hip fractures, using national standards and data collection to monitor and improve performance.
Journal Article
Delivering surgical education: a specialist surgical society and undergraduate student collaboration
by
Garg, Sunil
,
Singh, Bijayendra
,
Ahluwalia, Raju
in
Collaboration
,
College students
,
Consultants
2023
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.
Journal Article
MultiAgency, prospective, exploratory, non-intervention, cohort Study on Human Impact Exposure oNboard high-speed boats (MASHIEN): protocol
2025
IntroductionHigh-speed boat operations expose personnel to slamming-induced impacts, which can lead to musculoskeletal injuries and cognitive impairments. Despite existing safety measures, regulations and protocols, the risk of injuries remains significant. The MultiAgency, prospective, exploratory, non-intervention, cohort Study on Human Impact Exposure oNboard high-speed boats study aims to investigate the nature and magnitude of these impacts, their acute and long-term health effects, and potential injury prevention strategies to improve operational safety and performance.Methods and analysisThis is an ongoing multicentre, prospective, non-intervention, observational cohort study. The first participant was enrolled on 23 August 2024. High-speed boat operators log self-reported pain data via a smartphone app, using a Visual Analogue Scale and pain drawings. Triaxial accelerometers are installed on boat hulls and worn by participants to measure impact exposure. Data analysis assesses correlations between exposure and reported pain, enabling the identification of risk factors and the development of safety guidelines for high-speed boat operations.Ethics and disseminationThe study has received ethical approval from the relevant ethics committees, including the Swedish Ethics Review Authority (no. 2022-04931-01). All participants will provide informed consent before enrolment. The findings will be disseminated through technical reports, articles in peer-reviewed journals, conference presentations and direct engagement with military and maritime stakeholders to enhance training protocols and safety measures.Trial registration numberNCT05299736.
Journal Article
Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol
by
Gemperle Mannion, Elke
,
Scott, Chloe E H
,
Clement, Nicholas David
in
adult orthopaedics
,
adult surgery
,
Arthroplasty, Replacement, Knee - methods
2023
IntroductionRobotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems.Methods and analysisThe Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems.Ethics and disseminationThe trial has been approved by an ethics committee for patient participation (East Midlands—Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate.Trial registration numberISRCTN27624068.
Journal Article
Patient expectations for opioid analgesia following orthopaedic surgery
by
Spears, Thomas M
,
Harrison, James M
,
Balazs, George C
in
adult orthopaedics
,
Analgesics
,
Data analysis
2022
Correspondence to George C Balazs, Investigation Performed at Naval Medical Center Portsmouth, 620 John Paul Jones Cir, Portsmouth, VA 23708, USA; gcbalazs@gmail.com Orthopaedic surgeons are the third highest opioid prescribing speciality in the USA. 1 Studies have consistently shown that most postoperative opioids go unused, 2–5 and that there is a direct relationship between the quantity of opioids prescribed and the likelihood of prolonged use/misuse of opioids following surgery. 6 Currently published guidelines place a strong emphasis on managing patient expectations for postoperative analgesia, but no study has reported actual patient expectations for opioid management following orthopaedic surgery. Following Institutional Review Board approval, a three-question anonymous survey was provided to all patients seen for any reason in our multi-subspeciality orthopaedic surgery clinic in May 2018. Upwards of 20% of the patients engage in ‘doctor shopping’ for additional opioid prescriptions after traumatic orthopaedic injuries. 7 8 In a study of 207 patients with trauma, Gangavalli et al reported that 19% felt their pain medication was under-prescribed, 12% admitted to taking more than the prescribed dosage and 9% admitted to obtaining opioids from other sources than their physician.
Journal Article
‘Going through the motions’; a rich account of the complexity of the anterior cruciate ligament reconstruction pathway, a UK qualitative study
2024
ObjectivesThis study aimed to understand the lived experiences of patients on the anterior cruciate ligament reconstruction (ACLR) pathway up to 3 months before, 3 months after and 1 year after surgery. Study objectives were to explore (1) patient experiences of preoperative and postoperative treatment, (2) views of/involvement in prehabilitation and (3) sources and consistency of healthcare advice.DesignSemi-structured interviews analysed using reflexive thematic analysis.SettingMidlands, England.ParticipantsPurposive sample of 18 participants aged 18–45. Three identified as female and 15 as male. Participants’ ethnic origin was white (n=14), Indian (n=2), British Asian (n=1) and Pakistani (n=1). 10 participants were awaiting ACLR, six were 3months postsurgery and two were 1 year postsurgery.ResultsParticipants gave a rich account of ACLR pathway experiences discussing negative impacts of the injury, difficulties with navigating the pathway and making decisions about surgery. Interacting with healthcare professionals and managing the variety of resources, advice and opinions were also highlighted as challenges. Participants reflected on their preoperative journey accounting a wide spectrum of expectations and realities of returning to work and physical activity postoperatively. Prehabilitation was perceived to offer an advantage to recovery, mental well-being, injury knowledge, postoperative rehabilitation and supports a faster return to physical activity. Five themes were identified:Injury experience, impact and support.Navigating the treatment pathway.Sense making in the preoperative period.Uncertainty, expectations and reality of the postsurgical period.Balancing resources, advice and opinions.ConclusionThis study has illuminated patient experiences of the National Health Service (NHS) ACLR pathway, novel to the evidence base.The results highlight the perceived shortcomings in patient support. They also demonstrate the difficulty patients face when navigating the NHS system, communicating with clinicians, making decisions about treatment and managing conflicting sources of healthcare advice. These problems are more prominent than previously recognised in the literature.RegistrationClinicalTrials.gov Identifier: NCT05529511.
Journal Article
Registry-based cohort study comparing percentages of patients reaching PASS for knee function outcomes after revision ACLR compared to primary ACLR
by
Herman, Zachary J
,
Senorski, Eric Hamrin
,
Grassi, Alberto
in
Activities of daily living
,
Adult
,
Adult orthopaedics
2024
ObjectivesReaching the Patient-Acceptable Symptom State (PASS) threshold for the Knee injury and Osteoarthritis Outcome Score (KOOS) has previously been reported to successfully identify individuals experiencing clinical success after anterior cruciate ligament reconstruction (ACLR). Thus, the objectives of this study were to examine and compare the percentages of patients meeting PASS thresholds for the different KOOS subscales 1 year postoperatively after primary ACLR compared with revision ACLR (rACLR) and multiply revised ACLR (mrACLR), and second, to examine the predictors for reaching PASS for KOOS Quality of Life (QoL) and Function in Sport and Recreation (Sport/Rec) after mrACLR.DesignProspective observational registry study.SettingThe data used in this study was obtained from the Swedish National Ligament Registry and collected between 2005 and 2020.ParticipantsThe study sample was divided into three different groups: (1) primary ACLR, (2) rACLR and (3) mrACLR. Data on patient demographic, injury and surgical characteristics were obtained as well as mean 1-year postoperative scores for KOOS subscales and the per cent of patients meeting PASS for each subscale. Additionally, the predictors of reaching PASS for KOOS Sport/Rec, and QoL subscales were evaluated in patients undergoing mrACLR.ResultsOf the 22 928 patients included in the study, 1144 underwent rACLR and 36 underwent mrACLR. Across all KOOS subscales, the percentage of patients meeting PASS thresholds was statistically lower for rACLR compared with primary ACLR (KOOS Symptoms 22.5% vs 32.9%, KOOS Pain 84.9% vs 92.9%, KOOS Activities of Daily Living 23.5% vs 31.4%, KOOS Sport/Rec 26.3% vs 45.6%, KOOS QoL 26.9% vs 51.4%). Percentages of patients reaching PASS thresholds for all KOOS subscales were comparable between patients undergoing rACLR versus mrACLR. No predictive factors were found to be associated with reaching PASS for KOOS QoL and KOOS Sport/Rec 1 year postoperatively after mrACLR.ConclusionPatients undergoing ACLR in the revision setting had lower rates of reaching acceptable symptom states for functional knee outcomes than those undergoing primary ACLR.Level of evidenceProspective observational registry study, level of evidence II.
Journal Article
Timing of orthopaedic surgical interventions and factors contributing to delays in femoral fracture management among adults in South Africa: insights from a prospective cohort study
2026
ObjectivesTo determine the time intervals between injury and orthopaedic admission, admission and surgery, and postsurgery length of stay and to elucidate factors contributing to delays in accessing orthopaedic services.DesignProspective cohort study.SettingA tertiary hospital in the rural Eastern Cape province of South Africa.Participants413 adult patients admitted with femur fractures between January 2024 and July 2024.Primary and secondary outcome measuresThe primary outcome was the time interval from injury to surgical fixation. Secondary outcomes included time from admission to surgery, length of hospital stay and reasons for delays.ResultsOf 413 patients, only 22% (n=91) received surgical intervention within 48 hours of admission. The median time from injury to admission was 4 days (IQR 0–12), and injury to surgery was 13 days (IQR 0–713). Systemic factors, including limited theatre capacity and bed shortages, were the main reasons for delays. In the multivariate analysis, cardiac disease (adjusted OR, AOR=9.62), diabetes mellitus (AOR=4.36) and a Glasgow Coma Scale score of <8 (AOR=30.17) were significantly associated with higher mortality rates.ConclusionsSignificant delays in femoral fracture fixation were observed, with fewer than 10% receiving surgery within 48 hours of injury. Addressing surgical capacity and referral pathways is essential to improving timely access to care.
Journal Article