Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol.

INTRODUCTION: Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective. METHODS AND ANALYSIS: Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation.The trial's target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site.The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the East Midlands-Nottingham 2 Research Ethics Committee on 30 March 2023.Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels. TRIAL REGISTRATION NUMBER: ISRCTN17972668.

An analysis of the effect of the COVID-19-induced joint replacement deficit in England, Wales, and Northern Ireland suggests recovery will be protracted.

Aims: The COVID-19 pandemic has disrupted the provision of arthroplasty services in England, Wales, and Northern Ireland. This study aimed to quantify the backlog, analyze national trends, and predict time to recovery. Methods: We performed an analysis of the mandatory prospective national registry of all independent and publicly funded hip, knee, shoulder, elbow, and ankle replacements in England, Wales, and Northern Ireland between January 2019 and December 2022 inclusive, totalling 729,642 operations. The deficit was calculated per year compared to a continuation of 2019 volume. Total deficit of cases between 2020 to 2022 was expressed as a percentage of 2019 volume. Sub-analyses were performed based on procedure type, country, and unit sector. Results: Between January 2020 and December 2022, there was a deficit of 158,994 joint replacements. This is equivalent to over two-thirds of a year of normal expected operating activity (71.6%). There were 104,724 (-47.1%) fewer performed in 2020, 41,928 (-18.9%) fewer performed in 2021, and 12,342 (-5.6%) fewer performed in 2022, respectively, than in 2019. Independent-sector procedures increased to make it the predominant arthroplasty provider (53% in 2022). NHS activity was 73.2% of 2019 levels, while independent activity increased to 126.8%. Wales (-136.3%) and Northern Ireland (-121.3%) recorded deficits of more than a year's worth of procedures, substantially more than England (-66.7%). It would take until 2031 to eliminate this deficit with an immediate expansion of capacity over 2019 levels by 10%. Conclusion: The arthroplasty deficit following the COVID-19 pandemic is now equivalent to over two-thirds of a year of normal operating activity, and continues to increase. Patients awaiting different types of arthroplasty, in each country, have been affected disproportionately. A rapid and significant expansion in services is required to address the deficit, and will still take many years to rectify.

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.

A Meta-Analysis to Evaluate Implant Survival and Benefits of the Use of Dual Mobility Constructs in Total Hip Replacement Following Hip Fracture.

Total hip replacement (THR) is commonly performed to treat hip fractures. Dual-mobility constructs (DMCs) are increasingly used for this indication. The aim of this study was to use evidence synthesis techniques to estimate net all-cause construct survival for THR with DMC performed for hip fracture. Additionally, we aimed to investigate and describe differences in all-cause construct survival (if present) between THRs performed with DMC (DMC-THR) or with a conventional bearing construct following hip fracture. We performed a systematic review and meta-analysis of published studies (including joint registries), including DMC-THR for hip fracture which provided Kaplan-Meier (KM) survival estimates. The primary outcome was all-cause construct survival over time. The study was prospectively registered on PROSPERO (CRD42020173117). A total of 557 papers and 17 registry reports were identified. Six studies (four registry reports, one matched-pair cohort study utilising joint registry data, and one single-institution case series) met the inclusion criteria, including 17,370 DMC THRs and 167,377 conventional THRs. Five-year KM survival estimates (95% confidence intervals) were similar at 95.4% (94.9 to 95.8%) for DMC-THR and 96.2% (96.0 to 96.4%) for conventional THR. The relative risk of revision for DMC-THR at five years was 1.21 (1.05 to 1.41). These results suggest that DMC-THR has a lower all-cause survival than conventional THR following hip fracture. This analysis does not support the routine use of DMC-THR over conventional bearing THR.

Reverse total shoulder replacement versus anatomical total shoulder replacement for osteoarthritis: population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England.

OBJECTIVES: To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. DESIGN: Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. SETTING: Public hospitals and publicly funded procedures at private hospitals in England, 2012-20. PARTICIPANTS: Adults aged 60 years or older who underwent RTSR or TSR for osteoarthritis with intact rotator cuff tendons. Patients were identified from the National Joint Registry and linked to NHS Hospital Episode Statistics and civil registration mortality data. Propensity score matching and inverse probability of treatment weighting were used to balance the study groups. MAIN OUTCOME MEASURES: The main outcome measure was revision surgery. Secondary outcome measures included serious adverse events within 90 days, reoperations within 12 months, prolonged hospital stay (more than three nights), change in Oxford Shoulder Score (preoperative to six month postoperative), and lifetime costs to the healthcare service. RESULTS: The propensity score matched population comprised 7124 RTSR or TSR procedures (126 were revised), and the inverse probability of treatment weighted population comprised 12 968 procedures (294 were revised) with a maximum follow-up of 8.75 years. RTSR had a reduced hazard ratio of revision in the first three years (hazard ratio local minimum 0.33, 95% confidence interval 0.18 to 0.59) with no clinically important difference in revision-free restricted mean survival time, and a reduced relative risk of reoperations at 12 months (odds ratio 0.45, 95% confidence interval 0.25 to 0.83) with an absolute risk difference of -0.51% (95% confidence interval -0.89 to -0.13). Serious adverse events and prolonged hospital stay risks, change in Oxford Shoulder Score, and modelled mean lifetime costs were similar. Outcomes remained consistent after weighting. CONCLUSIONS: This study's findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact rotator cuff tendons. Despite a significant difference in the risk profiles of revision surgery over time, no statistically significant and clinically important differences between RTSR and TSR were found in terms of long term revision surgery, serious adverse events, reoperations, prolonged hospital stay, or lifetime healthcare costs.

The FAME trial study protocol: In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention?

Aims: Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient's ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. Methods: This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment. Anticipated impact: The 12-month results will be presented and published internationally. This is anticipated to be the only pragmatic trial reporting outcomes comparing surgical with non-surgical treatment in unstable ankle fractures in younger adults (aged 60 years and younger), and, as such, will inform the National Institute for Health and Care Excellence (NICE) 'non-complex fracture' recommendations at their scheduled update in 2024. A report of long-term outcomes at five years will be produced by January 2027.

Is it possible to predict which patients are most likely to benefit from intra-articular corticosteroid injections? A systematic review.

AIM: Intra-articular corticosteroid injections (IACIs) can reduce osteoarthritis-related pain, with differing levels of response across patient groups. This systematic review investigates what is known about the positive and negative predictors of outcomes in patients with osteoarthritis who undergo IACIs. METHODS: We systematically searched the Medline, Embase, and Cochrane databases to May 2023 for studies that evaluated patients undergoing IACIs for osteoarthritis and reported on predictors of outcomes in these patients. RESULTS: Eight studies were included. Two were placebo-controlled trials, six were observational studies. Due to the heterogeneity of outcomes and variables between the studies, it was not possible to pool the results for formal meta-analysis. Higher baseline pain, older age, higher BMI, lower range of movement, higher Kellgren-Lawrence radiographic score, joint effusion, and aspiration were shown to be predictors of a positive response to IACIs in some of the included studies. However, other studies showed no difference in response with these variables, or a negative correlation with response. Sex, smoking, mental health status, hypertension/ischaemic heart disease, diabetes mellitus, duration of symptoms, and socioeconomic status did not demonstrate any correlation with the prediction of positive or negative outcomes after IACIs. CONCLUSION: Several patient features have been identified as positive predictors of outcomes following IACIs. However, this systematic review has identified inconsistent and variable findings across the existing literature. Further research with standardization of IACI administration and outcome measures is required to facilitate further analysis of the reliability and significance of predictive factors for response to IACIs.

Development and application of simulation modelling for orthopaedic elective resource planning in England.

OBJECTIVES: This study aimed to develop a simulation model to support orthopaedic elective capacity planning. METHODS: An open-source, generalisable discrete-event simulation was developed, including a web-based application. The model used anonymised patient records between 2016 and 2019 of elective orthopaedic procedures from a National Health Service (NHS) Trust in England. In this paper, it is used to investigate scenarios including resourcing (beds and theatres) and productivity (lengths of stay, delayed discharges and theatre activity) to support planning for meeting new NHS targets aimed at reducing elective orthopaedic surgical backlogs in a proposed ring-fenced orthopaedic surgical facility. The simulation is interactive and intended for use by health service planners and clinicians. RESULTS: A higher number of beds (65-70) than the proposed number (40 beds) will be required if lengths of stay and delayed discharge rates remain unchanged. Reducing lengths of stay in line with national benchmarks reduces bed utilisation to an estimated 60%, allowing for additional theatre activity such as weekend working. Further, reducing the proportion of patients with a delayed discharge by 75% reduces bed utilisation to below 40%, even with weekend working. A range of other scenarios can also be investigated directly by NHS planners using the interactive web app. CONCLUSIONS: The simulation model is intended to support capacity planning of orthopaedic elective services by identifying a balance of capacity across theatres and beds and predicting the impact of productivity measures on capacity requirements. It is applicable beyond the study site and can be adapted for other specialties.

How long does a shoulder replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 10 years of follow-up.

BACKGROUND: Shoulder replacement is an increasingly common treatment for end-stage degenerative shoulder conditions. Some shoulder replacements are unsuccessful and additional operations might be required. It is important for patients and clinicians to know how long shoulder replacements last and how effectively they reduce pain and improve function. This study aims to determine the longevity and long-term efficacy of shoulder replacements. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and Embase from their inception to Sept 24, 2019, for case series and registry data reporting 10-year or longer survival of total shoulder replacements, humeral hemiarthroplasties, and reverse total shoulder replacements of a specific brand of implant. Survival, implant, and patient-reported outcome measures data were extracted. The primary outcome was implant survival. We reviewed and analysed national joint replacement registries separately. We weighted each series by SE and calculated a pooled survival estimate at years 10, 15, and 20. For patient-reported outcome measures we pooled the standardised mean difference at 10 years. This study is registered with PROSPERO, CRD42019140221. FINDINGS: 927 non-duplicate articles were identified by our search, nine articles (reporting ten series) were eligible for analysis of survival and six articles were eligible for analysis of patient reported outcomes. The ten series reported all-cause survival of 529 total shoulder replacements and 364 humeral hemiarthroplasties; no series for reverse total shoulder replacement met the inclusion criteria. The estimated 10-year survival for total shoulder replacement was 94·6% (95% CI 93·6-97·6) and humeral hemiarthroplasties was 90·4% (87·0-94·0). A single registry contributed 7651 total shoulder replacements, 1395 humeral hemiarthroplasties, and 7953 reverse total shoulder replacements. The pooled registry 10-year survival was 92·0% (95% CI 91·0-93·0) for total shoulder replacement, 85·5% (83·3-87·7) for humeral hemiarthroplasties, and 94·4% (93·4-95·7) for patients with osteoarthritis who had reverse total shoulder replacement and 93·6% (91·1-95·8) for patients with rotator cuff arthropathy who had reverse total shoulder replacement. Pooled 10-year patient-reported outcome measures showed a substantial improvement from baseline scores, with a standardised mean difference of 2·13 (95% CI 1·93-2·34). INTERPRETATION: Our data show that approximately 90% of shoulder replacements last for longer than 10 years and patient-reported benefits are sustained. Our findings will be of use to surgeons and patients in the informed consent process and to health-care providers for resource planning. FUNDING: The National Institute for Health Research, the National Joint Registry for England, Wales, Northern Ireland, and Isle of Man, and the Royal College of Surgeons of England.

Risk factors for dislocation after primary total hip replacement: a systematic review and meta-analysis of 125 studies involving approximately five million hip replacements.

BACKGROUND: Dislocation following total hip replacement is associated with repeated admissions to hospital and substantial costs to the health system. Factors influencing dislocation following primary total hip replacement are not well understood. We aimed to assess the association of various factors with dislocation risk following primary total hip replacement. METHODS: We did a systematic review and meta-analysis of longitudinal studies reporting associations of patient-related, surgery-related, implant-related, and hospital-related factors with dislocation risk after primary total hip replacement. We searched MEDLINE, Embase, Web of Science, and the Cochrane Library for all relevant articles published up to March 8, 2019. Summary measures of association were calculated with relative risks (RRs) and 95% CIs. This study is registered on PROSPERO, number CRD42019121378. FINDINGS: We identified 149 articles based on 125 unique studies with data on 4 633 935 primary total hip replacements and 35 264 dislocations. The incidence of dislocation ranged from 0·12% to 16·13%, with an overall pooled incidence of 2·10% (95% CI 1·83-2·38) over a weighted mean follow-up duration of 6 years. Based on the median year of data collection, a significant decline in dislocation rates was observed from 1971 to 2015. The risk of dislocation did not differ significantly between male versus female patients (RR 0·97; 95% CI 0·88-1·08), was higher in those aged 70 years and older than in those younger than 70 years (1·27; 1·02-1·57), and was lower in those from high versus low income groups (0·79; 0·74-0·85). White ethnicity (only when compared with Asian ethnicity), drug use disorder, and social deprivation were significantly associated with increased dislocation risk. The risk of dislocation was higher in patients with body-mass index (BMI) of 30 kg/m2 or higher than in those with BMI lower than 30 kg/m2 (RR 1·38; 95% CI 1·03-1·85). Medical factors and those related to surgical history that were significantly associated with increased dislocation risk included neurological disorder, psychiatric disease, comorbidity indices, previous surgery including spinal fusion, and surgical indications including avascular necrosis, rheumatoid arthritis, inflammatory arthritis, and osteonecrosis. Surgical factors such as the anterolateral, direct anterior, or lateral approach, and posterior approach with short external rotator and capsule repair were significantly associated with reduced dislocation risk. At the implant level, larger femoral head diameters, elevated acetabular liners, dual mobility cups, cemented fixations, and standard femoral neck lengths significantly reduced the risk of dislocation. Hospital-related factors such as experienced surgeons and high surgeon procedure volume significantly reduced the risk of dislocation. INTERPRETATION: Dislocation following primary total hip replacement has declined over time. Surgical approaches that reduce dislocation risk can be used by clinicians during primary total hip replacement, and alternative bearings such as dual mobility can be used in individuals at high risk of dislocation. Modifiable risk factors such as high BMI and comorbidities might also be amenable to optimisation before surgery. FUNDING: National Institute for Health Research.