Unicompartmental knee arthroplasty (UKA) is associated with an accelerated recovery, improved functional outcomes, and retention of anatomical knee kinematics when compared to manual total knee arthroplasty (mTKA). UKA is not universally employed by all surgeons as there is a higher revision risk when compared to mTKA. Robotic arm-assisted (ra) UKA enables the surgeon to position the prosthesis more accurately when compared to manual UKA, and is associated with improved functional outcomes and a lower early revision risk. Non-randomized data suggests that, when compared to mTKA, raUKA has a clinically meaningful greater functional benefit. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of raUKA compared to mTKA for individuals with isolated medial compartment osteoarthritis (OA). The total versus robotic-assisted unicompartmental knee arthroplasty (TRAKER) trial is a patient- and assessor-blinded, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary knee arthroplasty for primary medial compartment OA at a single NHS hospital (ClinicalTrials.gov NCT05290818). Participants will be randomly allocated on a 1:2 basis to either raUKA or mTKA, respectively. The primary analysis will compare the Oxford Knee Score (OKS) six months after surgery. Secondary outcomes measured at three, six, and 12 months include the OKS, Forgotten Joint Score, patient expectations, EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (EQ-VAS), patient satisfaction, range of motion, postoperative complications, need for further surgery, resource use, and financial costs. Cost-effectiveness will be measured over a ten-year time span. A total of 159 patients will be randomized (n = 53 raUKA vs n = 106 mTKA) to obtain 80% power to detect a five-point difference in OKS between the groups six months after surgery.Aims
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Aims. Control of acute pain following knee arthroplasty (KA) with a perioperative peripheral nerve block (PNB) may improve functional outcomes and reduce the risk of chronic postoperative knee pain (CPKP). The aims of this study were to assess whether a PNB influences patient-reported outcomes and risk of CPKP at one year following KA. Methods. A retrospective study was conducted over a two-year period and included 3,338 patients who underwent KA, of whom 1,434 (43.0%) had a lower limb PNB. A total of 2,588 patients (77.6%) completed and returned their one-year follow-up questionnaire. The Oxford Knee Score (OKS) and pain component (OKS-PS), EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (VAS) were collected preoperatively and at one year postoperatively. Patient satisfaction was also recorded at one year. The OKS-PS was used to define CPKP at one year. Results. The PNB group were younger (mean difference (MD) 0.7 years, 95% CI 0.0 to 1.3; p = 0.039), had a worse OKS (MD 0.7, 95% CI 0.1 to 1.3; p = 0.027), and were more likely to have had a spinal anaesthesia relative to a general anaesthetic (odds ratio 4.2, 95% CI 3.23 to 5.45; p < 0.001). When adjusting for confounding factors, patients in the PNB group had a significantly reduced improvement in their OKS (MD -0.9, 95% CI -1.6 to -0.1; p = 0.022), which may not be clinically meaningful. There were no significant differences in the OKS-PS (p = 0.068), EQ-5D (p = 0.313), or EQ-VAS (0.855) between the groups when adjusting for confounding factors. When adjusting for confounding factors using binary regression analysis, there were no differences in patient satisfaction (p = 0.132) or in the risk of CPKP (p = 0.794) according to PNB group. Conclusion. PNBs were independently associated with worse knee-specific outcomes, but whether these are clinically meaningful is not clear, as the difference was less than the minimal clinically important difference. Furthermore, PNBs were not independently associated with differences in
The Bracing Adolescent Idiopathic Scoliosis (BASIS) study is a randomized controlled non-inferiority pragmatic trial of ‘full-time bracing’ (FTB) compared to ‘night-time bracing’ (NTB) for the treatment of adolescent idiopathic scoliosis (AIS). We anticipated that recruiting patients to BASIS would be challenging, as it is a paediatric trial comparing two markedly different bracing pathways. No previous studies have compared the experiences of AIS patients treated with FTB to those treated with NTB. This qualitative study was embedded in BASIS to explore families’ perspectives of BASIS, to inform trial communication, and to identify strategies to support patients treated in a brace. Semi-structured interviews were conducted with parents (n = 26) and young people (n = 21) who had been invited to participate in BASIS at ten of the 22 UK paediatric spine services in hospitals recruiting to BASIS. Audio-recorded interviews were transcribed and analyzed thematically.Aims
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Hip fractures commonly occur in older patients, with high levels of frailty and comorbidity. Many of these patients have limited mobility before their fracture, and even after surgery, their mobility may remain limited. It is therefore not surprising that they are at a high risk of developing pressure sores, particularly on their heels, and a variety of devices and interventions have been proposed to reduce this risk. Foam or air mattresses, designed to reduce contact pressure on the patient’s whole body, are now routinely used in many healthcare systems. However, there is wide variation in their design. We developed the WHiTE 14;PRESSURE 3 trial to address the lack of evidence in this area. This is a three-arm multicentre randomized trial including health economic evaluation and recruiting patients from NHS hospitals in the UK. The trial compares standard strategies for the prevention of pressure sores with standard care plus a constant low-pressure device and with standard care plus a heel off-loading device. This annotation describes the development of this trial. Cite this article:
The aim of this study was to evaluate the suitability, against an accepted international standard, of a linked hip fracture registry and routinely collected administrative dataset in England to embed and deliver randomized controlled trials (RCTs). First, a bespoke cohort of individuals sustaining hip fractures between 2011 and 2016 was generated from the National Hip Fracture Database (NHFD) and linked to individual Hospital Episode Statistics (HES) records and mortality data. Second, in order to explore the availability and distribution of outcomes available in linked HES-Office of National Statistics (ONS) data, a more contemporary cohort with incident hip fracture was identified within HES between January 2014 and December 2018. Distributions of the outcomes within the HES-ONS dataset were reported using standard statistical summaries; descriptive characteristics of the NHFD and linked HES-ONS dataset were reported in line with the Clinical Trials Transformation Initiative recommendations for registry-enabled trials.Aims
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Aims. The primary aim of this study is to compare mobility status of patients receiving oral oxycodone with those receiving subcutaneous alfentanil as analgesic methods prior to mobilization to help physiotherapy compliance after hip fracture surgery. The secondary aims are to assess postoperative pain,
Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts.Aims
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In the UK, multidisciplinary teamwork for patients with hip fracture has been shown to reduce mortality and improves
Lower limb fractures are common in low- and middle-income countries (LMICs) and represent a significant burden to the existing orthopaedic surgical infrastructure. In high income country (HIC) settings, internal fixation is the standard of care due to its superior outcomes. In LMICs, external fixation is often the surgical treatment of choice due to limited supplies, cost considerations, and its perceived lower complication rate. The aim of this systematic review protocol is identifying differences in rates of infection, nonunion, and malunion of extra-articular femoral and tibial shaft fractures in LMICs treated with either internal or external fixation. This systematic review protocol describes a broad search of multiple databases to identify eligible papers. Studies must be published after 2000, include at least five patients, patients must be aged > 16 years or treated as skeletally mature, and the paper must describe a fracture of interest and at least one of our primary outcomes of interest. We did not place restrictions on language or journal. All abstracts and full texts will be screened and extracted by two independent reviewers. Risk of bias and quality of evidence will be analyzed using standardized appraisal tools. A random-effects meta-analysis followed by a subgroup analysis will be performed, given the anticipated heterogeneity among studies, if sufficient data are available.Aims
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The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with loss to follow-up and mortality risk. Long-term follow-up of a randomized controlled trial was undertaken. A total of 212 patients were allocated a Triathlon or a Kinemax TKA. Patients were assessed preoperatively, and one, three, eight, and 12 years postoperatively using the Oxford Knee Score (OKS). Reasons for patient lost to follow-up, mortality, and revision were recorded.Aims
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Aims. The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function,
Aims. Rotator cuff disease (RCD) can considerably decrease quality of life. Here, we investigated whether
Aims. It is well described that patients with bone and joint infections (BJIs) commonly experience significant functional impairment and disability. Published literature is lacking on the impact of BJIs on mental health. Therefore, the aim of this study was to assess
Aims. The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial. Methods. The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and
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
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Aims. 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). Methods. 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. Results. The base case analysis found participants in the compression bandage group accrued marginally fewer QALYs, on average, compared with those in the standard bandage group (reduction of 0.0050 QALYs (95% confidence interval (CI) -0.0051 to -0.0049)), and accumulated additional mean costs (incremental cost of £52.68 per participant (95% CI 50.56 to 54.80)). Findings remained robust to assumptions tested in sensitivity analyses, although considerable uncertainty surrounded the outcome estimates. Conclusion. Use of a two-layer compression bandage is marginally less effective in terms of
Aims. Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. Methods. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure
Aims. 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. Methods. 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
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. 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.Aims
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