Aims. To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation. Methods. We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or ‘group’) response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional. Results. Between 4 August 2020 and 4 August 2021, shoulder experts from 47 hospitals in the UK completed the study. There were 106 participants (consultant upper limb orthopaedic surgeons, n = 50; consultant radiologists, n = 52; consultant
Aims. Hip disease is common in children with cerebral palsy (CP) and can decrease quality of life and function. Surveillance programmes exist to improve outcomes by treating hip disease at an early stage using radiological surveillance. However, studies and surveillance programmes report different radiological outcomes, making it difficult to compare. We aimed to identify the most important radiological measurements and develop a core measurement set (CMS) for clinical practice, research, and surveillance programmes. Methods. A systematic review identified a list of measurements previously used in studies reporting radiological hip outcomes in children with CP. These measurements informed a two-round Delphi study, conducted among orthopaedic surgeons and specialist
Aims. This Delphi study assessed the challenges of diagnosing soft-tissue knee injuries (STKIs) in acute settings among orthopaedic healthcare stakeholders. Methods. This modified e-Delphi study consisted of three rounds and involved 32 orthopaedic healthcare stakeholders, including
The development of spinal deformity in children with underlying neurodisability can affect their ability to function and impact on their quality of life, as well as compromise provision of nursing care. Patients with neuromuscular spinal deformity are among the most challenging due to the number and complexity of medical comorbidities that increase the risk for severe intraoperative or postoperative complications. A multidisciplinary approach is mandatory at every stage to ensure that all nonoperative measures have been applied, and that the treatment goals have been clearly defined and agreed with the family. This will involve input from multiple specialities, including allied healthcare professionals, such as
Aims. This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Methods. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse,
Aims. To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV). Methods. A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons,
Aims. Patients undergoing limb reconstruction surgery often face a challenging and lengthy process to complete their treatment journey. The majority of existing outcome measures do not adequately capture the patient-reported outcomes relevant to this patient group in a single measure. Following a previous systematic review, the Stanmore Limb Reconstruction Score (SLRS) was designed with the intent to address this need for an effective instrument to measure patient-reported outcomes in limb reconstruction patients. We aim to assess the face validity of this score in a pilot study. Methods. The SLRS was designed following structured interviews with several groups including patients who have undergone limb reconstruction surgery, limb reconstruction surgeons, specialist nurses, and
Perthes’ disease is an idiopathic avascular necrosis of the developing femoral head, often causing deformity that impairs physical function. Current treatments aim to optimize the joint reaction force across the hip by enhancing congruency between the acetabulum and femoral head. Despite a century of research, there is no consensus regarding the optimal treatment. The aim of this study was to describe the experiences of children, their families, and clinicians when considering the treatment of Perthes’ disease. A qualitative study gathered information from children and their families affected by Perthes’ disease, along with treating clinicians. Interviews followed a coding framework, with the interview schedule informed by behavioural theory and patient and public involvement. Transcripts were analyzed using the framework method.Aims
Methods
Reimers migration percentage (MP) is a key measure to inform decision-making around the management of hip displacement in cerebral palsy (CP). The aim of this study is to assess validity and inter- and intra-rater reliability of a novel method of measuring MP using a smart phone app (HipScreen (HS) app). A total of 20 pelvis radiographs (40 hips) were used to measure MP by using the HS app. Measurements were performed by five different members of the multidisciplinary team, with varying levels of expertise in MP measurement. The same measurements were repeated two weeks later. A senior orthopaedic surgeon measured the MP on picture archiving and communication system (PACS) as the gold standard and repeated the measurements using HS app. Pearson’s correlation coefficient (r) was used to compare PACS measurements and all HS app measurements and assess validity. Intraclass correlation coefficient (ICC) was used to assess intra- and inter-rater reliability.Aims
Methods
The Ponseti method is the gold standard treatment for congenital talipes equinovarus (CTEV), with the British Consensus Statement providing a benchmark for standard of care. Meeting these standards and providing expert care while maintaining geographical accessibility can pose a service delivery challenge. A novel ‘Hub and Spoke’ Shared Care model was initiated to deliver Ponseti treatment for CTEV, while addressing standard of care and resource allocation. The aim of this study was to assess feasibility and outcomes of the corrective phase of Ponseti service delivery using this model. Patients with idiopathic CTEV were seen in their local hospitals (‘Spokes’) for initial diagnosis and casting, followed by referral to the tertiary hospital (‘Hub’) for tenotomy. Non-idiopathic CTEV was managed solely by the Hub. Primary and secondary outcomes were achieving primary correction, and complication rates resulting in early transfer to the Hub, respectively. Consecutive data were prospectively collected and compared between patients allocated to Hub or Spokes. Mann-Whitney U test, Wilcoxon signed-rank test, or chi-squared tests were used for analysis (alpha-priori = 0.05, two-tailed significance).Aims
Methods
There remains a lack of consensus regarding the management of chronic anterior sternoclavicular joint (SCJ) instability. This study aimed to assess whether a standardized treatment algorithm (incorporating physiotherapy and surgery and based on the presence of trauma) could successfully guide management and reduce the number needing surgery. Patients with chronic anterior SCJ instability managed between April 2007 and April 2019 with a standardized treatment algorithm were divided into non-traumatic (offered physiotherapy) and traumatic (offered surgery) groups and evaluated at discharge. Subsequently, midterm outcomes were assessed via a postal questionnaire with a subjective SCJ stability score, Oxford Shoulder Instability Score (OSIS, adapted for the SCJ), and pain visual analogue scale (VAS), with analysis on an intention-to-treat basis.Aims
Methods
An objective technological solution for tracking adherence to at-home shoulder physiotherapy is important for improving patient engagement and rehabilitation outcomes, but remains a significant challenge. The aim of this research was to evaluate performance of machine-learning (ML) methodologies for detecting and classifying inertial data collected during in-clinic and at-home shoulder physiotherapy exercise. A smartwatch was used to collect inertial data from 42 patients performing shoulder physiotherapy exercises for rotator cuff injuries in both in-clinic and at-home settings. A two-stage ML approach was used to detect out-of-distribution (OOD) data (to remove non-exercise data) and subsequently for classification of exercises. We evaluated the performance impact of grouping exercises by motion type, inclusion of non-exercise data for algorithm training, and a patient-specific approach to exercise classification. Algorithm performance was evaluated using both in-clinic and at-home data.Aims
Methods
Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis.Aims
Methods
In the UK, multidisciplinary teamwork for patients with hip fracture has been shown to reduce mortality and improves health-related quality of life for patients, while also reducing hospital bed days and associated healthcare costs. However, despite rapidly increasing numbers of fragility fractures, multidisciplinary shared care is rare in low- and middle-income countries around the world. The HIPCARE trial will test the introduction of multidisciplinary care pathways in five low- and middle-income countries in South and Southeast Asia, with the aim to improve patients’ quality of life and reduce healthcare costs. Cite this article:
A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.Aims
Methods
Aims. The aim of this study was to produce clinical consensus recommendations about the non-surgical treatment of children with Perthes’ disease. The recommendations are intended to support clinical practice in a condition for which there is no robust evidence to guide optimal care. Methods. A two-round, modified Delphi study was conducted online. An advisory group of children’s orthopaedic specialists consisting of
Aims. Perthes’ disease is a condition which leads to necrosis of the femoral head. It is most commonly reported in children aged four to nine years, with recent statistics suggesting it affects around five per 100,000 children in the UK. Current treatment for the condition aims to maintain the best possible environment for the disease process to run its natural course. Management typically includes physiotherapy with or without surgical intervention. Physiotherapy intervention often will include strengthening/stretching programmes, exercise/activity advice, and, in some centres, will include intervention, such as hydrotherapy. There is significant variation in care with no consensus on which treatment option is best. The importance of work in this area has been demonstrated by the British Society for Children’s Orthopaedic Surgery through the James Lind Alliance’s prioritization of work to determine/identify surgical versus non-surgical management of Perthes’ disease. It was identified as the fourth-highest priority for paediatric lower limb surgery research in 2018. Methods. Five UK NHS centres, including those from the NEWS (North, East, West and South Yorkshire) orthopaedic group, contributed to this case review, with each entre providing clinical data from a minimum of five children. Information regarding both orthopaedic and physiotherapeutic management over a two-year post-diagnosis period was reviewed. Results. Data were extracted from the clinical records of 32 children diagnosed with Perthes’ disease; seven boys and 25 girls. The mean age of the children at diagnosis was 6.16 years (standard deviation (SD) 3.001). In all, 26 children were referred for physiotherapy. In the two-year period following diagnosis, children were seen a median of 7.5 times (interquartile range (IQR) 4.25 to 11) by an orthopaedic surgeon, and a median of 9.5 times (IQR 8 to 18.25) by a
Aims. The aim of this randomized trial was to compare the functional outcome of two different surgical approaches to the hip in patients with a femoral neck fracture treated with a hemiarthroplasty. Patients and Methods. A total of 150 patients who were treated between February 2014 and July 2017 were included. Patients were allocated to undergo hemiarthroplasty using either an anterolateral or a direct lateral approach, and were followed for 12 months. The mean age of the patients was 81 years (69 to 90), and 109 were women (73%). Functional outcome measures, assessed by a
Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.Aims
Methods
The aim of this study was to gain a consensus for best practice of the assessment and management of children with idiopathic toe walking (ITW) in order to provide a benchmark for practitioners and guide the best consistent care. An established Delphi approach with predetermined steps and degree of agreement based on a standardized protocol was used to determine consensus. The steering group members and Delphi survey participants included members from the British Society of Children’s Orthopaedic Surgery (BSCOS) and the Association of Paediatric Chartered Physiotherapists (APCP). The statements included definition, assessment, treatment indications, nonoperative and operative interventions, and outcomes. Descriptive statistics were used for analysis of the Delphi survey results. The AGREE checklist was followed for reporting the results.Aims
Methods
Objectives . A rigorous approach to developing, delivering and documenting
rehabilitation within randomised controlled trials of surgical interventions
is required to underpin the generation of reliable and usable evidence.
This article describes the key processes used to ensure provision
of good quality and comparable rehabilitation to all participants
of a multi-centre randomised controlled trial comparing surgery
with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information
leaflet on self-care during sling immobilisation, the development
of a basic treatment physiotherapy protocol that received input
and endorsement by specialist
To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.Aims
Methods
Rotator cuff disease (RCD) can considerably decrease quality of life. Here, we investigated whether health-related quality of life (HRQoL) influences the need for surgery in patients with RCD. We performed an analysis of 417 patients with symptomatic RCD who were recruited from two hospitals between June 2008 and December 2014 to be randomized to receive non-surgical or surgical treatment. After a three-month rehabilitation period, 36-Item Short-Form Health Survey questionnaire (SF-36), shoulder pain (visual analogue scale (VAS)), and shoulder function (Constant-Murley score) data were available from 191 still-symptomatic patients who were eligible for surgery. A control group was formed from 87 excluded patients who were no longer eligible for surgery due to relief of symptoms.Aims
Methods
This study compared patient-reported outcomes of three total knee arthroplasty (TKA) designs from one manufacturer: one cruciate-retaining (CR) design, and two cruciate-sacrificing designs, anterior-stabilized (AS) and posterior-stabilized (PS). Patients scheduled for primary TKA were included in a single-centre, prospective, three-armed, blinded randomized trial (n = 216; 72 per group). After intraoperative confirmation of posterior cruciate ligament (PCL) integrity, patients were randomly allocated to receive a CR, AS, or PS design from the same TKA system. Insertion of an AS or PS design required PCL resection. The primary outcome was the mean score of all five subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS) at two-year follow-up. Secondary outcomes included all KOOS subscales, Oxford Knee Score, EuroQol five-dimension health questionnaire, EuroQol visual analogue scale, range of motion (ROM), and willingness to undergo the operation again. Patient satisfaction was also assessed.Aims
Methods
To investigate the impact of consecutive perioperative care transitions on in-hospital recovery of patients who had primary total knee arthroplasty (TKA) over an 11-year period. This observational cohort study used electronic health record data from all patients undergoing preoperative screening for primary TKA at a Northern Netherlands hospital between 2009 and 2020. In this timeframe, three perioperative care transitions were divided into four periods: Baseline care (Joint Care, n = 171; May 2009 to August 2010), Function-tailored (n = 404; September 2010 to October 2013), Fast-track (n = 721; November 2013 to May 2018), and Prehabilitation (n = 601; June 2018 to December 2020). In-hospital recovery was measured using inpatient recovery of activities (IROA), length of stay (LOS), and discharge to preoperative living situation (PLS). Multivariable regression models were used to analyze the impact of each perioperative care transition on in-hospital recovery.Aims
Methods
Day-case success rates after primary total hip arthroplasty (THA), total knee arthroplasty (TKA), and medial unicompartmental knee arthroplasty (mUKA) may vary, and detailed data are needed on causes of not being discharged. The aim of this study was to analyze the association between surgical procedure type and successful day-case surgery, and to analyze causes of not being discharged on the day of surgery when eligible and scheduled for day-case THA, TKA, and mUKA. A multicentre, prospective consecutive cohort study was carried out from September 2022 to August 2023. Patients were screened for day-case eligibility using well defined inclusion and exclusion criteria, and discharged when fulfilling predetermined discharge criteria. Day-case eligible patients were scheduled for surgery with intended start of surgery before 1.00 pm.Aims
Methods
The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
Methods
To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.Aims
Methods
Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.Aims
Methods
A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening. A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group.Aims
Methods
Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients. This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively.Aims
Methods
Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014).Aims
Methods
Complete ruptures of the ulnar collateral ligament (UCL) of the thumb are a common injury, yet little is known about their current management in the UK. The objective of this study was to assess the way complete UCL ruptures are managed in the UK. We carried out a multicentre, survey-based cross-sectional study in 37 UK centres over a 16-month period from June 2022 to September 2023. The survey results were analyzed descriptively.Aims
Methods
Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus. Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.Aims
Methods
The objectives of this study were to investigate the patient characteristics and mortality of Vancouver type B periprosthetic femoral fractures (PFF) subgroups divided into two groups according to femoral component stability and to compare postoperative clinical outcomes according to treatment in Vancouver type B2 and B3 fractures. A total of 126 Vancouver type B fractures were analyzed from 2010 to 2019 in 11 associated centres' database (named TRON). We divided the patients into two Vancouver type B subtypes according to implant stability. Patient demographics and functional scores were assessed in the Vancouver type B subtypes. We estimated the mortality according to various patient characteristics and clinical outcomes between the open reduction internal fixation (ORIF) and revision arthroplasty (revision) groups in patients with unstable subtype.Aims
Methods
Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection.Aims
Methods
Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines.Aims
Methods
Brace treatment is the cornerstone of managing developmental dysplasia of the hip (DDH), yet there is a lack of evidence-based treatment protocols, which results in wide variations in practice. To resolve this, we have developed a comprehensive nonoperative treatment protocol conforming to published consensus principles, with well-defined a priori criteria for inclusion and successful treatment. This was a single-centre, prospective, longitudinal cohort study of a consecutive series of infants with ultrasound-confirmed DDH who underwent a comprehensive nonoperative brace management protocol in a unified multidisciplinary clinic between January 2012 and December 2016 with five-year follow-up radiographs. The radiological outcomes were acetabular index-lateral edge (AI-L), acetabular index-sourcil (AI-S), centre-edge angle (CEA), acetabular depth ratio (ADR), International Hip Dysplasia Institute (IHDI) grade, and evidence of avascular necrosis (AVN). At five years, each hip was classified as normal (< 1 SD), borderline dysplastic (1 to 2 SDs), or dysplastic (> 2 SDs) based on validated radiological norm-referenced values.Aims
Methods
Tenosynovial giant cell tumour (TGCT) is a rare benign tumour of the musculoskeletal system. Surgical management is fraught with challenges due to high recurrence rates. The aim of this study was to describe surgical treatment and evaluate surgical outcomes of TGCT at an Australian tertiary referral centre for musculoskeletal tumours and to identify factors affecting recurrence rates. A prospective database of all patients with TGCT surgically managed by two orthopaedic oncology surgeons was reviewed. All cases irrespective of previous treatment were included and patients without follow-up were excluded. Pertinent tumour characteristics and surgical outcomes were collected for analysis.Aims
Methods
People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.Aims
Methods
The aim of this study was to determine the effectiveness of home-based prehabilitation on pre- and postoperative outcomes in participants awaiting total knee (TKA) and hip arthroplasty (THA). A systematic review with meta-analysis of randomized controlled trials (RCTs) of prehabilitation interventions for TKA and THA. MEDLINE, CINAHL, ProQuest, PubMed, Cochrane Library, and Google Scholar databases were searched from inception to October 2022. Evidence was assessed by the PEDro scale and the Cochrane risk-of-bias (ROB2) tool.Aims
Methods
The aim of this study was to gain an agreement on the management of idiopathic congenital talipes equinovarus (CTEV) up to walking age in order to provide a benchmark for practitioners and guide consistent, high-quality care for children with CTEV. The consensus process followed an established Delphi approach with a predetermined degree of agreement. The process included the following steps: establishing a steering group; steering group meetings, generating statements, and checking them against the literature; a two-round Delphi survey; and final consensus meeting. The steering group members and Delphi survey participants were all British Society of Children’s Orthopaedic Surgery (BSCOS) members. Descriptive statistics were used for analysis of the Delphi survey results. The Appraisal of Guidelines for Research & Evaluation checklist was followed for reporting of the results.Aims
Methods
The evidence demonstrating the superiority of early MRI has led to increased use of MRI in clinical pathways for acute wrist trauma. The aim of this study was to describe the radiological characteristics and the inter-observer reliability of a new MRI based classification system for scaphoid injuries in a consecutive series of patients. We identified 80 consecutive patients with acute scaphoid injuries at one centre who had presented within four weeks of injury. The radiographs and MRI scans were assessed by four observers, two radiologists, and two hand surgeons, using both pre-existing classifications and a new MRI based classification tool, the Oxford Scaphoid MRI Assessment Rating Tool (OxSMART). The OxSMART was used to categorize scaphoid injuries into three grades: contusion (grade 1); unicortical fracture (grade 2); and complete bicortical fracture (grade 3).Aims
Methods
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. 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.Aims
Methods
We introduced a self-care pathway for minimally displaced distal radius fractures, which involved the patient being discharged from a Virtual Fracture Clinic (VFC) without a physical review and being provided with written instructions on how to remove their own cast or splint at home, plus advice on exercises and return to function. All patients managed via this protocol between March and October 2020 were contacted by a medical secretary at a minimum of six months post-injury. The patients were asked to complete the Patient-Rated Wrist Evaluation (PRWE), a satisfaction questionnaire, advise if they had required surgery and/or contacted any health professional, and were also asked for any recommendations on how to improve the service. A review with a hand surgeon was organized if required, and a cost analysis was also conducted.Aims
Methods
The aim of this study was to inform the epidemiology and treatment of slipped capital femoral epiphysis (SCFE). This was an anonymized comprehensive cohort study, with a nested consented cohort, following the the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework. A total of 143 of 144 hospitals treating SCFE in Great Britain participated over an 18-month period. Patients were cross-checked against national administrative data and potential missing patients were identified. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants.Aims
Methods
The purpose of this study was to compare the clinical outcomes, mortalities, implant survival rates, and complications of total knee arthroplasty (TKA) in patients with or without hepatitis B virus (HBV) infection over at least ten years of follow-up. From January 2008 to December 2010, 266 TKAs were performed in 169 patients with HBV (HBV group). A total of 169 propensity score–matched patients without HBV were chosen for the control group in a one-to-one ratio. Then, the clinical outcomes, mortalities, implant survival rates, and complications of TKA in the two groups were compared. The mean follow-up periods were 11.7 years (10.5 to 13.4) in the HBV group and 11.8 years (11.5 to 12.4) in the control group.Aims
Methods
A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.Aims
Methods
The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a cost-effectiveness analysis. A cost-utility analysis was performed alongside a randomized controlled trial. A total of 50 patients were randomized to each group. We prospectively collected data on resource use during the first year post-fracture, and estimated costs of initial treatment, further operations, physiotherapy, home nursing, and production loss. Health-related quality of life was based on the Euro-QoL five-dimension, five-level (EQ-5D-5L) utility index, and quality-adjusted life-years (QALYs) were calculated.Aims
Methods
The aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD). Relevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families.Aims
Methods
This study aims to estimate economic outcomes associated with 30-day deep surgical site infection (SSI) from closed surgical wounds in patients with lower limb fractures following major trauma. Data from the Wound Healing in Surgery for Trauma (WHiST) trial, which collected outcomes from 1,547 adult participants using self-completed questionnaires over a six-month period following major trauma, was used as the basis of this empirical investigation. Associations between deep SSI and NHS and personal social services (PSS) costs (£, 2017 to 2018 prices), and between deep SSI and quality-adjusted life years (QALYs), were estimated using descriptive and multivariable analyses. Sensitivity analyses assessed the impact of uncertainty surrounding components of the economic analyses.Aims
Methods
Psychoeducative prehabilitation to optimize surgical outcomes is relatively novel in spinal fusion surgery and, like most rehabilitation treatments, they are rarely well specified. Spinal fusion patients experience anxieties perioperatively about pain and immobility, which might prolong hospital length of stay (LOS). The aim of this prospective cohort study was to determine if a Preoperative Spinal Education (POSE) programme, specified using the Rehabilitation Treatment Specification System (RTSS) and designed to normalize expectations and reduce anxieties, was safe and reduced LOS. POSE was offered to 150 prospective patients over ten months (December 2018 to November 2019) Some chose to attend (Attend-POSE) and some did not attend (DNA-POSE). A third independent retrospective group of 150 patients (mean age 57.9 years (SD 14.8), 50.6% female) received surgery prior to POSE (pre-POSE). POSE consisted of an in-person 60-minute education with accompanying literature, specified using the RTSS as psychoeducative treatment components designed to optimize cognitive/affective representations of thoughts/feelings, and normalize anxieties about surgery and its aftermath. Across-group age, sex, median LOS, perioperative complications, and readmission rates were assessed using appropriate statistical tests.Aims
Methods
Waiting times for arthroplasty surgery in Northern Ireland are among the longest in the NHS, which have been further lengthened by the onset of the COVID-19 global pandemic in March 2020. The Department of Health in Northern Ireland has announced a new Elective Care Framework (ECF), with the framework proposing that by March 2026 no patient will wait more than 52 weeks for inpatient/day case treatment. We aimed to assess the feasibility of achieving this with reference to total hip arthroplasty (THA) and total knee arthroplasty (TKA). Mathematical modelling was undertaken to calculate when the ECF targets will be achieved for THA and TKA, as well as the time when waiting lists for THA and TKA will be cleared. The number of patients currently on the waiting list and percentage operating capacity relative to pre-COVID-19 capacity was used to determine future projections.Aims
Methods
Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA. A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS4) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures.Aims
Methods
Current National Institute for Health and Clinical Excellence (NICE) guidance advises that MRI direct from the emergency department (ED) should be considered for suspected scaphoid fractures. This study reports the current management of suspected scaphoid fractures in the UK and assesses adherence with NICE guidance. This national cross-sectional study was carried out at 87 NHS centres in the UK involving 122 EDs and 184 minor injuries units (MIUs). The primary outcome was availability of MRI imaging direct from the ED. We also report the specifics of patient management pathways for suspected scaphoid fractures in EDs, MIUs, and orthopaedic services. Overall, 62 of 87 centres (71%) had a guideline for the management of suspected scaphoid fractures.Aims
Methods
The aim of this study is to assess the impact of a pilot enhanced recovery after surgery (ERAS) programme on length of stay (LOS) and post-discharge resource usage via service evaluation and cost analysis. Between May and December 2019, 100 patients requiring hip or knee arthroplasty were enrolled with the intention that each would have a preadmission discharge plan, a preoperative education class with nominated helper, a day of surgery admission and mobilization, a day one discharge, and access to a 24/7 dedicated helpline. Each was matched with a patient under the pre-existing pathway from the previous year.Aims
Methods
In 2020, the COVID-19 pandemic meant that proceeding with elective surgery was restricted to minimize exposure on wards. In order to maintain throughput of elective cases, our hospital (St Michaels Hospital, Toronto, Canada) was forced to convert as many cases as possible to same-day procedures rather than overnight admission. In this retrospective analysis, we review the cases performed as same-day arthroplasty surgeries compared to the same period in the previous 12 months. We conducted a retrospective analysis of patients undergoing total hip and knee arthroplasties over a three-month period between October and December in 2019, and again in 2020, in the middle of the COVID-19 pandemic. Patient demographics, number of outpatient primary arthroplasty cases, length of stay for admissions, 30-day readmission, and complications were collated.Aims
Methods
To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis.Aims
Methods
Day-case arthroplasty is gaining popularity in Europe. We report outcomes from the first 12 months following implementation of a day-case pathway for unicompartmental knee arthroplasty (UKA) and total hip arthroplasty (THA) in an NHS hospital. A total of 47 total hip arthroplasty (THA) and 24 unicompartmental knee arthroplasty (UKA) patients were selected for the day-case arthroplasty pathway, based on preoperative fitness and agreement to participate. Data were likewise collected for a matched control group (n = 58) who followed the standard pathway three months prior to the implementation of the day-case pathway. We report same-day discharge (SDD) success, reasons for delayed discharge, and patient-reported outcomes. Overall length of stay (LOS) for all lower limb arthroplasty was recorded to determine the wider impact of implementing a day-case pathway.Aims
Methods
This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot. A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders.Aims
Methods
We present the development of a day-case total hip arthroplasty (THA) pathway in a UK National Health Service institution in conjunction with an extensive evidence-based summary of the interventions used to achieve successful day-case THA to which the protocol is founded upon. We performed a prospective audit of day-case THA in our institution as we reinitiate our full capacity elective services. In parallel, we performed a review of the literature reporting complication or readmission rates at ≥ 30-day postoperative following day-case THA. Electronic searches were performed using four databases from the date of inception to November 2020. Relevant studies were identified, data extracted, and qualitative synthesis performed.Aims
Methods
It is unclear whether acute plate fixation facilitates earlier return of normal shoulder function following a displaced mid-shaft clavicular fracture compared with nonoperative management when union occurs. The primary aim of this study was to establish whether acute plate fixation was associated with a greater return of normal shoulder function when compared with nonoperative management in patients who unite their fractures. The secondary aim was to investigate whether there were identifiable predictors associated with return of normal shoulder function in patients who achieve union with nonoperative management. Patient data from a randomized controlled trial were used to compare acute plate fixation with nonoperative management of united fractures. Return of shoulder function was based on the age- and sex-matched Disabilities of the Arm, Shoulder and Hand (DASH) scores for the cohort. Independent predictors of an early recovery of normal shoulder function were investigated using a separate prospective series of consecutive nonoperative displaced mid-shaft clavicular fractures recruited over a two-year period (aged ≥ 16 years). Patient demographics and functional recovery were assessed over the six months post-injury using a standardized protocol.Aims
Methods
We studied the outcomes of hip and knee arthroplasties in a high-volume arthroplasty centre to determine if patients with morbid obesity (BMI ≥ 40 kg/m2) had unacceptably worse outcomes as compared to those with BMI < 40 kg/m2. In a two-year period, 4,711 patients had either total hip arthroplasty (THA; n = 2,370), total knee arthroplasty (TKA; n = 2,109), or unicompartmental knee arthroplasty (UKA; n = 232). Of these patients, 392 (8.3%) had morbid obesity. We compared duration of operation, anaesthetic time, length of stay (LOS), LOS > three days, out of hours attendance, emergency department attendance, readmission to hospital, return to theatre, and venous thromboembolism up to 90 days. Readmission for wound infection was recorded to one year. Oxford scores were recorded preoperatively and at one year postoperatively.Aims
Methods
This study aims to evaluate a new home medical stretching device called the Self Treatment Assisted Knee (STAK) tool to treat knee arthrofibrosis. 35 patients post-major knee surgery with arthrofibrosis and mean range of movement (ROM) of 68° were recruited. Both the STAK intervention and control group received standard physiotherapy for eight weeks, with the intervention group additionally using the STAK at home. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Scores (OKS) were collected at all timepoints. An acceptability and home exercise questionnaire capturing adherence was recorded after each of the interventions.Aims
Methods
The aim of this study was to explore parents and young people’s experience of having a medial epicondyle fracture, and their thoughts about the uncertainty regarding the optimal treatment. Families were identified after being invited to participate in a randomized controlled trial of surgery or no surgery for displaced medial epicondyle fractures of the humerus in children. A purposeful sample of 25 parents (22 females) and five young people (three females, mean age 11 years (7 to 14)) from 15 UK hospitals were interviewed a mean of 39 days (14 to 78) from injury. Qualitative interviews were informed by phenomenology and themes identified to convey participants’ experience.Aims
Methods
To determine the role of early MRI in the management of suspected scaphoid fractures. A total of 337 consecutive patients presenting to an emergency department (ED) following wrist trauma over a 12-month period were prospectively included in this service evaluation project. MRI was not required in 62 patients with clear diagnoses, and 17 patients were not managed as per pathway, leaving a total of 258 patients with normal scaphoid series radiographs who were then referred directly from ED for an acute wrist MRI scan. Patient demographics, clinical details, outcomes, and complications were recorded at a minimum of a year following injury.Aims
Methods
The primary aim was to assess the patient-perceived effect of restrictions imposed due to COVID-19 on rehabilitation following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Secondary aims were to assess perceived restrictions, influence on mental health, and functional outcome compared to patients undergoing surgery without restriction. During February and March 2020, 105 patients underwent THA (n = 48) or TKA (n = 57) and completed preoperative and six-month postoperative assessments. A cohort of 415 patients undergoing surgery in 2019 were used as the control. Patient demographic data, BMI, comorbidities, Oxford Hip Score (OHS) or Knee Score (OKS), and EuroQoL five-domain (EQ-5D) score were collected preoperatively and at six months postoperatively. At six months postoperatively, the 2020 patients were also asked to complete a questionnaire relating to the effect of the social restrictions on their outcome and their mental health.Aims
Methods
To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot. A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper.Aims
Methods
Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
To evaluate if union of clavicle fractures can be predicted at six weeks post-injury by the presence of bridging callus on ultrasound. Adult patients managed nonoperatively with a displaced mid-shaft clavicle were recruited prospectively. Ultrasound evaluation of the fracture was undertaken to determine if sonographic bridging callus was present. Clinical risk factors at six weeks were used to stratify patients at high risk of nonunion with a combination of Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) ≥ 40, fracture movement on examination, or absence of callus on radiograph.Aims
Methods
The gluteus minimus (GMin) and gluteus medius (GMed) have unique structural and functional segments that may be affected to varying degrees, by end-stage osteoarthritis (OA) and normal ageing. We used data from patients with end-stage OA and matched healthy controls to 1) quantify the atrophy of the GMin and GMed in the two groups and 2) describe the distinct patterns of the fatty infiltration in the different segments of the GMin and GMed in the two groups. A total of 39 patients with end-stage OA and 12 age- and sex frequency-matched healthy controls were prospectively enrolled in the study. Fatty infiltration within the different segments of the GMin and the GMed was assessed on MRI according to the semiquantitative classification system of Goutallier and normalized cross-sectional areas were measured.Aims
Methods
Cite this article:
Perthes’ disease is a condition leading to necrosis of the femoral head. It is most common in children aged four to nine years, affecting around one per 1,200 children in the UK. Management typically includes non-surgical treatment options, such as physiotherapy with/without surgical intervention. However, there is significant variation in care with no consensus on the most effective treatment option. This systematic review aims to evaluate the effectiveness of non-surgical interventions for the treatment of Perthes’ disease. Comparative studies (experimental or observational) of any non-surgical intervention compared directly with any alternative intervention (surgical, non-surgical or no intervention) were identified from: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMcare, Allied and Complementary Medicine Database (AMED), and the Physiotherapy Evidence Database (PEDro). Data were extracted on interventions compared and methodological quality. For post-intervention primary outcome of radiological scores (Stulberg and/or Mose), event rates for poor scores were calculated with significance values. Secondary outcomes included functional measures, such as range of movement, and patient-reported outcomes such as health-related quality of life.Aims
Methods
We hypothesized that the wide-awake local anaesthesia with no tourniquet (WALANT) technique is cost-effective, easy to use, safe, and reproducible, with a low learning curve towards mastery, having a high patient satisfaction rate. Furthermore, WALANT would be a suitable alternative for the austere and developing nation environments where lack of funds and resources are a common issue. This was a randomized control trial of 169 patients who required surgery for closed isolated distal radius fractures. The study was performed between March 2016 and April 2019 at a public sector level 1 trauma centre. General anaesthesia was used in 56 patients, Bier’s block in 58 patients, and WALANT in 55 patients. Data were collected on pre-, peri-, and postoperative parameters, clinical outcome, hospital costs, and patient satisfaction. One-way analysis of variance (ANOVA) was used with a p-value of 0.05 being significant.Aims
Methods
Virtual fracture clinics (VFCs) are being increasingly used to offer safe and efficient orthopaedic review without the requirement for face-to-face contact. With the onset of the COVID-19 pandemic, we sought to develop an online referral pathway that would allow us to provide definitive orthopaedic management plans and reduce face-to-face contact at the fracture clinics. All patients presenting to the emergency department from 21March 2020 with a musculoskeletal injury or potential musculoskeletal infection deemed to require orthopaedic input were discussed using a secure messaging app. A definitive management plan was communicated by an on-call senior orthopaedic decision-maker. We analyzed the time to decision, if further information was needed, and the referral outcome. An analysis of the orthopaedic referrals for the same period in 2019 was also performed as a comparison.Introduction
Methods
Elective surgery has been severely curtailed as a result of the COVID-19 pandemic. There is little evidence to guide surgeons in assessing what processes should be put in place to restart elective surgery safely in a time of endemic COVID-19 in the community. We used data from a stand-alone hospital admitting and operating on 91 trauma patients. All patients were screened on admission and 100% of patients have been followed-up after discharge to assess outcome.Aims
Methods
The adequate provision of personal protective equipment (PPE) for healthcare workers has come under considerable scrutiny during the COVID-19 pandemic. This study aimed to evaluate staff awareness of PPE guidance, perceptions of PPE measures, and concerns regarding PPE use while caring for COVID-19 patients. In addition, responses of doctors, nurses, and other healthcare professionals (OHCPs) were compared. The inclusion criteria were all staff working in clinical areas of the hospital. Staff were invited to take part using a link to an online questionnaire advertised by email, posters displayed in clinical areas, and social media. Questions grouped into the three key themes - staff awareness, perceptions, and concerns - were answered using a five-point Likert scale. The Kruskal-Wallis test was used to compare results across all three groups of staff.Aims
Methods
The aim of the British Association for Surgery of the Knee (BASK) Meniscal Consensus Project was to develop an evidence-based treatment guideline for patients with meniscal lesions of the knee. A formal consensus process was undertaken applying nominal group, Delphi, and appropriateness methods. Consensus was first reached on the terminology relating to the definition, investigation, and classification of meniscal lesions. A series of simulated clinical scenarios was then created and the appropriateness of arthroscopic meniscal surgery or nonoperative treatment in each scenario was rated by the group. The process was informed throughout by the latest published, and previously unpublished, clinical and epidemiological evidence. Scenarios were then grouped together based upon the similarity of clinical features and ratings to form the guideline for treatment. Feedback on the draft guideline was sought from the entire membership of BASK before final revisions and approval by the consensus group.Aims
Materials and Methods
The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness. The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping.Aims
Patients and Methods
High-quality clinical research in children’s orthopaedic surgery
has lagged behind other surgical subspecialties. This study used
a consensus-based approach to identify research priorities for clinical
trials in children’s orthopaedics. A modified Delphi technique was used, which involved an initial
scoping survey, a two-round Delphi process and an expert panel formed
of members of the British Society of Children’s Orthopaedic Surgery.
The survey was conducted amongst orthopaedic surgeons treating children
in the United Kingdom and Ireland.Aims
Methods
A trial-based comparison of the use of resources, costs and quality
of life outcomes of arthroscopic and open surgical management for
rotator cuff tears in the United Kingdom NHS was performed using
data from the United Kingdom Rotator Cuff Study (UKUFF) randomised
controlled trial. Using data from 273 patients, healthcare-related use of resources,
costs and quality-adjusted life years (QALYs) were estimated at
12 months and 24 months after surgery on an intention-to-treat basis
with adjustment for covariates. Uncertainty about the incremental
cost-effectiveness ratio for arthroscopic Aims
Patients and Methods
The aim of this study was to compare the effectiveness of a femoral
nerve block and a periarticular infiltration in the management of
early post-operative pain after total knee arthroplasty (TKA). A pragmatic, single centre, two arm parallel group, patient blinded,
randomised controlled trial was undertaken. All patients due for
TKA were eligible. Exclusion criteria included contraindications
to the medications involved in the study and patients with a neurological
abnormality of the lower limb. Patients received either a femoral
nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around
the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine
hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol
and 0.25 mg of adrenaline all diluted with 0.9% saline to make a
volume of 150 ml.Aims
Patients and Methods
In this cross sectional study, the impact and the efficacy of a surveillance programme for sarcomas of the extremities was analysed. All patients who had treatment with curative intent for a high-grade sarcoma and were diagnosed before 2014 were included and followed for a minimum of two years.Objectives
Methods
A fracture of the hip is the most common serious orthopaedic
injury, and surgical site infection (SSI) is one of the most significant
complications, resulting in increased mortality, prolonged hospital
stay and often the need for further surgery. Our aim was to determine
whether high dose dual antibiotic impregnated bone cement decreases the
rate of infection. A quasi-randomised study of 848 patients with an intracapsular
fracture of the hip was conducted in one large teaching hospital
on two sites. All were treated with a hemiarthroplasty. A total
of 448 patients received low dose single-antibiotic impregnated
cement (control group) and 400 patients received high dose dual-antibiotic impregnated
cement (intervention group). The primary outcome measure was deep
SSI at one year after surgery.Aims
Patients and Methods
Subtotal or total meniscectomy in the medial or lateral compartment
of the knee results in a high risk of future osteoarthritis. Meniscal
allograft transplantation has been performed for over thirty years
with the scientifically plausible hypothesis that it functions in
a similar way to a native meniscus. It is thought that a meniscal
allograft transplant has a chondroprotective effect, reducing symptoms
and the long-term risk of osteoarthritis. However, this hypothesis has
never been tested in a high-quality study on human participants.
This study aims to address this shortfall by performing a pilot
randomised controlled trial within the context of a comprehensive
cohort study design. Patients will be randomised to receive either meniscal transplant
or a non-operative, personalised knee therapy program. MRIs will
be performed every four months for one year. The primary endpoint
is the mean change in cartilage volume in the weight-bearing area
of the knee at one year post intervention. Secondary outcome measures
include the mean change in cartilage thickness, T2 maps, patient-reported
outcome measures, health economics assessment and complications.Objectives
Methods
Effective analgesia after total knee arthroplasty (TKA) improves
patient satisfaction, mobility and expedites discharge. This study
assessed whether continuous femoral nerve infusion (CFNI) was superior
to a single-shot femoral nerve block in primary TKA surgery completed
under subarachnoid blockade including morphine. We performed an adequately powered, prospective, randomised,
placebo-controlled trial comparing CFNI of 0.125% bupivacaine Objectives
Methods
To report the five-year results of a randomised controlled trial
examining the effectiveness of arthroscopic acromioplasty in the
treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two groups:
1) supervised exercise programme (n = 70, exercise group); and 2)
arthroscopic acromioplasty followed by a similar exercise programme
(n = 70, combined treatment group).Objectives
Methods
To conduct a pilot randomised controlled trial to evaluate the
feasibility of conducting a larger trial to evaluate the difference
in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores
at six months between patients with Achilles tendinopathy treated
with a platelet-rich plasma (PRP) injection compared with an eccentric
loading programme. Two groups of patients with mid-substance Achilles tendinopathy
were randomised to receive a PRP injection or an eccentric loading
programme. A total of 20 patients were randomised, with a mean age
of 49 years (35 to 66). All outcome measures were recorded at baseline,
six weeks, three months and six months.Objectives
Methods
There is conflicting evidence about the benefit
of using corticosteroid in periarticular injections for pain relief
after total knee arthroplasty (TKA). We carried out a double-blinded,
randomised controlled trial to assess the efficacy of using corticosteroid
in a periarticular injection to control pain after TKA. A total of 77 patients, 67 women and ten men, with a mean age
of 74 years (47 to 88) who were about to undergo unilateral TKA
were randomly assigned to have a periarticular injection with or
without corticosteroid. The primary outcome was post-operative pain
at rest during the first 24 hours after surgery, measured every
two hours using a visual analogue pain scale score. The cumulative
pain score was quantified using the area under the curve. The corticosteroid group had a significantly lower cumulative
pain score than the no-corticosteroid group during the first 24
hours after surgery (mean area under the curve 139, 0 to 560, and
264, 0 to 1460; p = 0.024). The rate of complications, including
surgical site infection, was not significantly different between
the two groups up to one year post-operatively. The addition of corticosteroid to the periarticular injection
significantly decreased early post-operative pain. Further studies
are needed to confirm the safety of corticosteroid in periarticular
injection.
Cite this article:
This pilot study reports the clinical outcomes
of a combination of partial subscapularis tendon transfer and small-head
hemiarthroplasty in patients with rotatator cuff arthropathy. A
total of 30 patients (30 shoulders; eight men and 22 women) with
a mean age of 74 years (55 to 84) were assessed at a mean follow-up
of 31 months (24 to 60). The inclusion criteria were painful cuff
tear arthropathy with normal deltoid function and a non-degenerative subscapularis
muscle and tendon and a preserved teres minor. Outcome was assessed using the University of California Los Angeles
score, the Japanese Orthopaedic Association score, and the Oxford
Shoulder Score. Radiographic measurements included the centre of
rotation distance and the length of the deltoid. All clinical scores were significantly improved post-operatively.
The active flexion and external rotation improved significantly
at the most recent follow-up (p <
0.035). Although the mean centre
of rotation distance changed significantly (p <
0.001), the mean
length of the deltoid did not change significantly from the pre-operative
value (p = 0.29). The change in the length of the deltoid with <
100° flexion was significantly less than that with >
100° (p <
0.001). Progressive erosion of the glenoid was seen in four patients.
No patient required revision or further surgery. A combination of partial subscapularis tendon transfer and small-head
hemiarthroplasty effectively restored function and relieved pain
in patients with rotator cuff arthropathy. Cite this article: 2015;97-B:1090–5.
The aim of this study was to review the role
of clinical trial networks in orthopaedic surgery. A total of two
electronic databases (MEDLINE and EMBASE) were searched from inception
to September 2013 with no language restrictions. Articles related
to randomised controlled trials (RCTs), research networks and orthopaedic
research, were identified and reviewed. The usefulness of trainee-led
research collaborations is reported and our knowledge of current
clinical trial infrastructure further supplements the review. Searching
yielded 818 titles and abstracts, of which 12 were suitable for
this review. Results are summarised and presented narratively under
the following headings: 1) identifying clinically relevant research
questions; 2) education and training; 3) conduct of multicentre
RCTs and 4) dissemination and adoption of trial results. This review
confirms growing international awareness of the important role research
networks play in supporting trials in orthopaedic surgery. Multidisciplinary
collaboration and adequate investment in trial infrastructure are crucial
for successful delivery of RCTs. Cite this article:
The surgical community is plagued with a reputation
for both failing to engage and to deliver on clinical research.
This is in part due to the absence of a strong research culture, however
it is also due to a multitude of barriers encountered in clinical
research; particularly those involving surgical interventions. ‘Trauma’
amplifies these barriers, owing to the unplanned nature of care,
unpredictable work patterns, the emergent nature of treatment and
complexities in the consent process. This review discusses the barriers
to clinical research in surgery, with a particular emphasis on trauma.
It considers how barriers may be overcome, with the aim to facilitate
future successful clinical research. Cite this article: