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Lancet (London, England) Jun 2024After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy.
METHODS
This was a pragmatic, multicentre, randomised, non-inferiority trial including 561 participants (aged ≥18 years) who received acute surgery for an unstable ankle fracture in 23 UK National Health Service (NHS) hospitals who were assigned to either a delayed weight-bearing (n=280) or an early weight-bearing rehabilitation strategy (n=281). Patients treated with a hindfoot nail, those who did not have protective ankle sensation (eg, peripheral neuropathy), did not have the capacity to consent, or did not have the ability to adhere to trial procedures were excluded. Neither participants nor clinicians were masked to the treatment. The primary outcome was ankle function measured using the Olerud and Molander Ankle Score (OMAS) at 4 months after randomisation, in the per-protocol population. The pre-specified non-inferiority OMAS margin was -6 points and superiority testing was included in the intention-to-treat population in the event of non-inferiority. The trial was prospectively registered with ISRCTN Registry, ISRCTN12883981, and the trial is closed to new participants.
FINDINGS
Primary outcome data were collected from 480 (86%) of 561 participants. Recruitment was conducted between Jan 13, 2020, and Oct 29, 2021. At 4 months after randomisation, the mean OMAS score was 65·9 in the early weight-bearing and 61·2 in the delayed weight-bearing group and adjusted mean difference was 4·47 (95% CI 0·58 to 8·37, p=0·024; superiority testing adjusted difference 4·42, 95% CI 0·53 to 8·32, p=0·026) in favour of early weight-bearing. 46 (16%) participants in the early weight-bearing group and 39 (14%) in the delayed weight-bearing group had one or more complications (adjusted odds ratio 1·18, 95% CI 0·80 to 1·75, p=0·40). The mean costs from the perspective of the NHS and personal social services in the early and delayed weight-bearing groups were £725 and £785, respectively (mean difference -£60 [95% CI -342 to 232]). The probability that early weight-bearing is cost-effective exceeded 80%.
INTERPRETATION
An early weight-bearing strategy was found to be clinically non-inferior and highly likely to be cost-effective compared with the current standard of care (delayed weight-bearing).
FUNDING
National Institute for Health and Care Research (NIHR), NIHR Barts Biomedical Research Centre, and NIHR Applied Research Collaboration Oxford and Thames Valley.
Topics: Humans; Weight-Bearing; Female; Male; Ankle Fractures; Middle Aged; Adult; Cost-Benefit Analysis; Time Factors; Treatment Outcome; Walking; United Kingdom; Aged
PubMed: 38848738
DOI: 10.1016/S0140-6736(24)00710-4 -
JAMA Network Open Jun 2024Rifampin-resistant tuberculosis treatment regimens require electrocardiographic (ECG) monitoring due to the use of multiple QTc-prolonging agents. Formal 12-lead ECG...
IMPORTANCE
Rifampin-resistant tuberculosis treatment regimens require electrocardiographic (ECG) monitoring due to the use of multiple QTc-prolonging agents. Formal 12-lead ECG devices represent a significant burden in resource-constrained clinics worldwide and a potential barrier to treatment scale-up in some settings.
OBJECTIVE
To evaluate the diagnostic accuracy of a handheld 6-lead ECG device within resource-constrained clinics.
DESIGN, SETTING, AND PARTICIPANTS
This diagnostic study was performed within a multicenter, pragmatic (broad eligibility criteria with no exclusions for randomized participants), phase 3 rifampin-resistant tuberculosis treatment trial (BEAT Tuberculosis [Building Evidence for Advancing New Treatment for Tuberculosis]) in South Africa. A total of 192 consecutive trial participants were assessed, and 191 were recruited for this substudy between January 21, 2021, and March 27, 2023. A low proportion (3 of 432 [0.7%]) of all screened trial participants were excluded due to a QTc interval greater than 450 milliseconds. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.
MAIN OUTCOMES AND MEASURES
Diagnostic accuracy, repeatability, and feasibility of a 6-lead ECG device.
RESULTS
A total of 191 participants (median age, 36 years [IQR, 28-45 years]; 81 female participants [42.4%]; 91 participants [47.6%] living with HIV) with a median of 4 clinic visits (IQR, 3-4 visits) contributed 2070 and 2015 12-lead and 6-lead ECG assessments, respectively. Across 170 participants attending 489 total clinic visits where valid triplicate QTc measurements were available for both devices, the mean 12-lead QTc measurement was 418 milliseconds (range, 321-519 milliseconds), and the mean 6-lead QTc measurement was 422 milliseconds (range, 288-574 milliseconds; proportion of variation explained, R2 = 0.4; P < .001). At a QTc interval threshold of 500 milliseconds, the 6-lead ECG device had a negative predictive value of 99.8% (95% CI, 98.8%-99.9%) and a positive predictive value of 16.7% (95% CI, 0.4%-64.1%). The normal expected range of within-individual variability of the 6-lead ECG device was high (±50.2 milliseconds [coefficient of variation, 6.0%]) relative to the 12-lead ECG device (±22.0 milliseconds [coefficient of variation, 2.7%]). The mean (SD) increase in the 12-lead QTc measurement during treatment was 10.1 (25.8) milliseconds, with 0.8% of clinic visits (4 of 489) having a QTc interval of 500 milliseconds or more.
CONCLUSIONS AND RELEVANCE
This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform 12-lead ECG monitoring in resource-constrained settings.
Topics: Humans; Female; Male; Adult; Electrocardiography; South Africa; Middle Aged; Long QT Syndrome; Reproducibility of Results; Tuberculosis, Multidrug-Resistant; Resource-Limited Settings
PubMed: 38848063
DOI: 10.1001/jamanetworkopen.2024.15576 -
PloS One 2024Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike...
BACKGROUND
Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike professionally led meetings, the aim is for decisions to be made by or with family members. Qualitative and mixed-method research with FGC participants tends to show positive experiences: most participants feel their voices are heard; FGCs facilitate family-driven solutions and closer relationships-within families and with social workers. Although there is existing literature on FGCs, there is a paucity of robust comparative UK evaluations, i.e., randomised controlled trials or quasi-experimental studies. Comparative studies internationally have focused on a narrow range of outcomes, not recognised the importance of context, and paid little attention to the quality of delivery. Some qualitative studies have considered process and context but there is scant measurement of these. The aims of this study are, firstly, to establish how FGCs improve outcomes for families and what factors vary their quality, and, secondly, to assess longer-term outcomes in terms of service use and associated costs.
METHODS
Given the importance of process and context, evaluation informed by realist and complex systems approaches is needed. This multi-method evaluation includes a survey of FGC services in all UK local authorities (n = 212) to map service provision; co-design of programme theory and evaluation measures with family members who have experienced an FGC (n = 16-24) and practitioners (n = 16-24) in two sites; a prospective single-arm study of FGC variability and outcomes after six months; and comparison of service use and costs in FGC participants (n≥300 families) and a control group (n≥1000) after two years using a quasi-experiment.
DISCUSSION
This is a pragmatic evaluation of an existing intervention, to identify what mechanisms and contexts influence effective process and longer-term outcomes. The study is registered with Research Registry (ref. 7432).
Topics: Humans; Family; Child; Female; Child Welfare; United Kingdom; Male; Surveys and Questionnaires
PubMed: 38843190
DOI: 10.1371/journal.pone.0300834 -
EClinicalMedicine Jul 2024There is uncertainty regarding how best to support patients with anorexia nervosa following inpatient or day care treatment. This study evaluated the impact of...
Efficacy and cost-effectiveness of a digital guided self-management intervention to support transition from intensive care to community care in anorexia nervosa (TRIANGLE): pragmatic multicentre randomised controlled trial and economic evaluation.
BACKGROUND
There is uncertainty regarding how best to support patients with anorexia nervosa following inpatient or day care treatment. This study evaluated the impact of augmenting intensive treatment with a digital, guided, self-management intervention (ECHOMANTRA) for patients with anorexia nervosa and their carers.
METHODS
In this pragmatic multicentre randomised controlled trial and economic evaluation, patients with a diagnosis of anorexia nervosa or atypical anorexia nervosa, aged 16+ and attending one of the 31 inpatient or day-patient services in the UK were randomised with one of their carers to receive ECHOMANTRA plus treatment as usual (TAU), or TAU alone. ECHOMANTRA was hosted on a digital platform and included a workbook, recovery-oriented video-clips and online facilitated groups (patients only, carers only, joint patient-carer). Participants were randomised on a 1:1 ratio using a minimisation algorithm to stratify by site (N = 31) and severity (defined by BMI <15 and ≥ 15 kg/m at baseline). The primary outcome was patient depression, anxiety, and stress at 12 months. Primary and secondary outcomes were compared between trial arms on an intention-to-treat basis (ITT). This trial is registered with the ISRSTN registry, ISRCTN14644379.
FINDINGS
Between July 01, 2017 and July 20, 2020, 371 patient-carer dyads were enrolled and randomly assigned to ECHOMANTRA + TAU (N = 185) or TAU alone (N = 186). There were no significant differences between trial arms with regards to the primary outcome (completed by N = 143 patients in the TAU group, Mean = 61.7, SD = 29.4 and N = 109 patients in the ECHOMANTRA + TAU group, Mean = 58.3, SD = 26.9; estimated mean difference 0.48 points; 95% CI -5.36 to 6.33; = 0.87). Differences on secondary outcomes were small and non-significant (standardised effect size estimates ≤0.25). Five patients died (2 from suicide and 3 from physical complications) over the course of the trial, and this was unrelated to their participation in the study.
INTERPRETATION
ECHOMANTRA added to TAU was not superior to TAU alone in reducing patient depression, anxiety, and stress symptoms. This may be explained by limited engagement with the intervention materials and changes in usual care practices since the beginning of the trial.
FUNDING
National Institute for Health Research (NIHR), under its Health Technology Assessment Programme (HTA) Programme (Grant Reference Number 14/68/09). NIHR Maudsley Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Psychology and Neuroscience, and King's College London. NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust.
PubMed: 38841708
DOI: 10.1016/j.eclinm.2024.102645 -
Integrative Medicine Research Jun 2024Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines,...
Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines.
BACKGROUND
Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported.
METHODS
ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity.
RESULTS
Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points ( = 13.2, range 2-22), needle retention time ( = 23.5 min, range 4-52), session length ( = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form.
CONCLUSION
To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs.
PROTOCOL REGISTRATION
The protocol of this study is registered at clinicaltrials.gov: NCT04880733.
PubMed: 38841077
DOI: 10.1016/j.imr.2024.101048 -
BMJ (Clinical Research Ed.) Jun 2024To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms.
DESIGN
Pragmatic, factorial randomised controlled trial.
SETTING
Primary care physicians in Ontario, Canada PARTICIPANTS: All primary care physicians were randomly assigned a group if they were eligible and actively prescribing antibiotics to patients 65 years or older. Physicians were excluded if had already volunteered to receive antibiotic prescribing feedback from another agency, or had opted out of the trial.
INTERVENTION
A letter was mailed in January 2022 to physicians with peer comparison antibiotic prescribing feedback compared with the control group who did not receive a letter (4:1 allocation). The intervention group was further randomised in a 2x2 factorial trial to evaluate case-mix adjusted versus unadjusted comparators, and emphasis, or not, on harms of antibiotics.
MAIN OUTCOME MEASURES
Antibiotic prescribing rate per 1000 patient visits for patients 65 years or older six months after intervention. Analysis was in the modified intention-to-treat population using Poisson regression.
RESULTS
5046 physicians were included and analysed: 1005 in control group and 4041 in intervention group (1016 case-mix adjusted data and harms messaging, 1006 with case-mix adjusted data and no harms messaging, 1006 unadjusted data and harms messaging, and 1013 unadjusted data and no harms messaging). At six months, mean antibiotic prescribing rate was 59.4 (standard deviation 42.0) in the control group and 56.0 (39.2) in the intervention group (relative rate 0.95 (95% confidence interval 0.94 to 0.96). Unnecessary antibiotic prescribing (0.89 (0.86 to 0.92)), prolonged duration prescriptions defined as more than seven days (0.85 (0.83 to 0.87)), and broad spectrum prescribing (0.94 (0.92 to 0.95)) were also significantly lower in the intervention group compared with the control group. Results were consistent at 12 months post intervention. No significant effect was seen for including emphasis on harms messaging. A small increase in antibiotic prescribing with case-mix adjusted reports was noted (1.01 (1.00 to 1.03)).
CONCLUSIONS
Peer comparison audit and feedback letters significantly reduced overall antibiotic prescribing with no benefit of case-mix adjustment or harms messaging. Antibiotic prescribing audit and feedback is a scalable and effective intervention and should be a routine quality improvement initiative in primary care.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04594200.
Topics: Humans; Anti-Bacterial Agents; Aged; Male; Female; Practice Patterns, Physicians'; Ontario; Physicians, Primary Care; Feedback; Postal Service; Drug Prescriptions
PubMed: 38839101
DOI: 10.1136/bmj-2024-079329 -
Therapeutic Advances in... 2024Long-acting injectable antipsychotics (LAIs) have advantages over oral antipsychotics (OAPs) in preventing relapse and hospitalization in chronically ill patients with...
Efficacy and safety of long-acting injectable oral antipsychotics in the treatment of patients with early-phase schizophrenia-spectrum disorders: a systematic review and meta-analysis.
BACKGROUND
Long-acting injectable antipsychotics (LAIs) have advantages over oral antipsychotics (OAPs) in preventing relapse and hospitalization in chronically ill patients with schizophrenia-spectrum disorders (SSDs), but evidence in patients with first-episode/recent-onset, that is, early-phase-SSDs is less clear.
OBJECTIVES
To assess the relative medium- and long-term efficacy and safety of LAIs OAPs in the maintenance treatment of patients with early-phase SSDs.
METHOD
We searched major electronic databases for head-to-head randomized controlled trials (RCTs) comparing LAIs and OAPs for the maintenance treatment of patients with early-phase-SSDs.
DESIGN
Pairwise, random-effects meta-analysis. Relapse/hospitalization and acceptability (all-cause discontinuation) measured at study-endpoint were co-primary outcomes, calculating risk ratios (RRs) with their 95% confidence intervals (CIs). Subgroup analyses sought to identify factors moderating differences in efficacy or acceptability between LAIs and OAPs.
RESULTS
Across 11 head-to-head RCTs ( = 2374, median age = 25.2 years, males = 68.4%, median illness duration = 45.8 weeks) lasting 13-104 (median = 78) weeks, no significant differences emerged between LAIs and OAPs for relapse/hospitalization prevention (RR = 0.79, 95%CI = 0.58-1.06, = 0.13) and acceptability (RR = 0.92, 95%CI = 0.80-1.05, = 0.20). The included trials were highly heterogeneous regarding methodology and patient populations. LAIs outperformed OAPs in preventing relapse/hospitalization in studies with stable patients (RR = 0.65, 95%CI = 0.45-0.92), pragmatic design (RR = 0.67, 95%CI = 0.54-0.82), and strict intent-to-treat approach (RR = 0.64, 95%CI = 0.52-0.80). Furthermore, LAIs were associated with better acceptability in studies with schizophrenia patients only (RR = 0.87, 95%CI = 0.79-0.95), longer illness duration (RR = 0.88, 95%CI = 0.80-0.97), unstable patients (RR = 0.89, 95%CI = 0.81-0.99) and allowed OAP supplementation of LAIs (RR = 0.90, 95%CI = 0.81-0.99).
CONCLUSION
LAIs and OAPs did not differ significantly regarding relapse prevention/hospitalization and acceptability. However, in nine subgroup analyses, LAIs were superior to OAPs in patients with EP-SSDs with indicators of higher quality and/or pragmatic design regarding relapse/hospitalization prevention (four subgroup analyses) and/or reduced all-cause discontinuation (five subgroup analyses), without any instance of OAP superiority LAIs. More high-quality pragmatic trials comparing LAIs with OAPs in EP-SSDs are needed.
TRIAL REGISTRATION
CRD42023407120 (PROSPERO).
PubMed: 38831918
DOI: 10.1177/20451253241257062 -
Implementation Science : IS Jun 2024HIV burden in the US among people who inject drugs (PWID) is driven by overlapping syndemic factors such as co-occurring health needs and environmental factors that...
BACKGROUND
HIV burden in the US among people who inject drugs (PWID) is driven by overlapping syndemic factors such as co-occurring health needs and environmental factors that synergize to produce worse health outcomes among PWID. This includes stigma, poverty, and limited healthcare access (e.g. medication to treat/prevent HIV and for opioid use disorder [MOUD]). Health services to address these complex needs, when they exist, are rarely located in proximity to each other or to the PWID who need them. Given the shifting drug use landscapes and geographic heterogeneity in the US, we evaluate a data-driven approach to guide the delivery of such services to PWID in local communities.
METHODS
We used a hybrid, type I, embedded, mixed method, data-driven approach to identify and characterize viable implementation neighborhoods for the HPTN 094 complex intervention, delivering integrated MOUD and HIV treatment/prevention through a mobile unit to PWID across five US cities. Applying the PRISM framework, we triangulated geographic and observational pre-implementation phase data (epidemiological overdose and HIV surveillance data) with two years of implementation phase data (weekly ecological assessments, study protocol meetings) to characterize environmental factors that affected the viability of implementation neighborhoods over time and across diverse settings.
RESULTS
Neighborhood-level drug use and geographic diversity alongside shifting socio-political factors (policing, surveillance, gentrification) differentially affected the utility of epidemiological data in identifying viable implementation neighborhoods across sites. In sites where PWID are more geographically dispersed, proximity to structural factors such as public transportation and spaces where PWID reside played a role in determining suitable implementation sites. The utility of leveraging additional data from local overdose and housing response systems to identify viable implementation neighborhoods was mixed.
CONCLUSIONS
Our findings suggest that data-driven approaches provide a contextually relevant pragmatic strategy to guide the real-time implementation of integrated care models to better meet the needs of PWID and help inform the scale-up of such complex interventions. This work highlights the utility of implementation science methods that attend to the impact of local community environmental factors on the implementation of complex interventions to PWID across diverse drug use, sociopolitical, and geographic landscapes in the US.
TRIAL REGISTRATION
ClincalTrials.gov, Registration Number: NCT04804072 . Registered 18 February 2021.
Topics: Humans; HIV Infections; Substance Abuse, Intravenous; United States; Opioid-Related Disorders; Implementation Science; Health Services Accessibility; Residence Characteristics; Female; Male; Social Stigma; Delivery of Health Care, Integrated
PubMed: 38831415
DOI: 10.1186/s13012-024-01363-x -
BMJ Open Jun 2024Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.
METHODS AND ANALYSIS
A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.
ETHICS AND DISSEMINATION
Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER
NCT04803747.
Topics: Humans; Tranexamic Acid; Antifibrinolytic Agents; Canada; Blood Loss, Surgical; Cross-Over Studies; Erythrocyte Transfusion; Organizational Policy
PubMed: 38830735
DOI: 10.1136/bmjopen-2024-084847 -
Bone & Joint Open Jun 2024During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the...
The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing: a pragmatic multicentre randomized controlled Trial (PART).
AIMS
During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon's decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.
METHODS
The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.
CONCLUSION
The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing.
PubMed: 38828864
DOI: 10.1302/2633-1462.56.BJO-2023-0154