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
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
Aims. The overall aim of this study was to determine the impact of deprivation with regard to quality of life, demographics, joint-specific function, attendances for unscheduled care, opioid and antidepressant use, having surgery elsewhere, and waiting times for surgery on patients awaiting total hip arthroplasty (THA) and total knee arthroplasty (TKA). Methods. Postal surveys were sent to 1,001 patients on the waiting list for THA or TKA in a single Northern Ireland NHS Trust, which consisted of the EuroQol five-dimension five-level questionnaire (EQ-5D-5L), visual analogue scores (EQ-VAS), and Oxford Hip and Knee Scores. Electronic records determined prescriptions since addition to the waiting list and out-of-hour GP and emergency department attendances. Deprivation quintiles were determined by the Northern Ireland Multiple Deprivation Measure 2017 using postcodes of home addresses. Results. Overall, 707 postal surveys were returned, of which 277 (39.2%) reported negative “worse than death”
Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated.Aims
Methods
Aims. The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis. Methods. This retrospective cohort study used Australian national arthroplasty registry data from January 2013 to January 2021 to identify participants who underwent elective staged BTKA with six to 24 months between procedures. The primary outcome was Oxford Knee Score (OKS) at six months postoperatively for the first TKA compared to the second TKA, adjusted for age and sex. Secondary outcomes compared six-month EuroQol five-dimension five-level (EQ-5D-5L) domain scores,
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
The primary aim of this study was to report the radiological outcomes of patients with a dorsally displaced distal radius fracture who were randomized to a moulded cast or surgical fixation with wires following manipulation and closed reduction of their fracture. The secondary aim was to correlate radiological outcomes with patient-reported outcome measures (PROMs) in the year following injury. Participants were recruited as part of DRAFFT2, a UK multicentre clinical trial. Participants were aged 16 years or over with a dorsally displaced distal radius fracture, and were eligible for the trial if they needed a manipulation of their fracture, as recommended by their treating surgeon. Participants were randomly allocated on a 1:1 ratio to moulded cast or Kirschner wires after manipulation of the fracture in the operating theatre. Standard posteroanterior and lateral radiographs were performed in the radiology department of participating centres at the time of the patient’s initial assessment in the emergency department and six weeks postoperatively. Intraoperative fluoroscopic images taken at the time of fracture reduction were also assessed.Aims
Methods
Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone. Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the “after weightbearing” images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft.Aims
Methods
We assessed the long-term outcomes of a large cohort of patients who have undergone a periacetabular osteotomy (PAO), and sought to validate a patient satisfaction questionnaire for use in a PAO cohort. All patients who had undergone a PAO from July 1998 to February 2013 were surveyed, with several patient-reported outcome measures (PROMs) and radiological measurements of preoperative acetabular dysplasia and postoperative correction also recorded. Patients were asked to rate their level of satisfaction with their operation in achieving pain relief, restoration of activities of daily living, ability to perform recreational activity, and their overall level of satisfaction with the procedure.Aims
Methods
Aims. The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS). Methods. All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups. Results. The median OMAS score was 85.0 for patients treated with RR, and 90.0 for patients treated with ODR (p = 0.384), indicating no significant difference between ODR and RR. The secondary outcome measures included the AOFAS (88.0 in the RR group and 90.0 for ODR; p = 0.722), FAOS (87.5 in the RR group and 92.9 for ODR; p = 0.399), and
To perform an incremental cost-utility analysis and assess the impact of differential costs and case volume on the cost-effectiveness of robotic arm-assisted unicompartmental knee arthroplasty (rUKA) compared to manual (mUKA). This was a five-year follow-up study of patients who were randomized to rUKA (n = 64) or mUKA (n = 65). Patients completed the EuroQol five-dimension questionnaire (EQ-5D) preoperatively, and at three months and one, two, and five years postoperatively, which was used to calculate quality-adjusted life years (QALYs) gained. Costs for the primary and additional surgery and healthcare costs were calculated.Aims
Methods
The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m2, or THA performed for pain relief in those with severely restricted mobility.Aims
Methods
Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design. Patients with end-stage osteoarthritis were enrolled in a prospective cohort at a single centre. The cohort consisted of 11 females and 11 males with mean age of 70.6 years (SD 3.5) and BMI of 31.0 kg/m2 (SD 5.7). Implant fixation was evaluated using RSA as well as Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score, Oxford Hip Score, Hip disability and Osteoarthritis Outcome Score, 38-item Short Form survey, and EuroQol five-dimension health questionnaire scores at two-year follow-up. At least one acetabular screw was used in all cases. RSA markers were inserted into the innominate bone and proximal femur with imaging at six weeks (baseline) and six, 12, and 24 months. Independent-samples Aims
Methods
To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration. We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map.Aims
Methods
Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems. In total, 44 patients with bilateral hip osteoarthritis were recruited from the outpatient clinic at a single tertiary orthopaedic centre. The patients were operated with bilateral one-stage total hip arthroplasty. The most painful hip was randomized to either Fitmore or CLS femoral component; the second hip was operated with the femoral component not used on the first side. Patients were evaluated at three and six months and at one, two, and five years postoperatively with patient-reported outcome measures, radiostereometric analysis, dual-energy X-ray absorptiometry, and conventional radiography. A total of 39 patients attended the follow-up visit at two years (primary outcome) and 35 patients at five years. The primary outcome was which hip the patient considered to have the best function at two years.Aims
Methods
To investigate health-related quality of life (HRQoL) of older adults (aged ≥ 60 years) after tibial plateau fracture (TPF) compared to preinjury and population matched values, and what aspects of treatment were most important to patients. We undertook a retrospective, case-control study of 67 patients at mean 3.5 years (SD 1.3; 1.3 to 6.1) after TPF (47 patients underwent fixation, and 20 nonoperative management). Patients completed EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, Lower Limb Function Scale (LEFS), and Oxford Knee Scores (OKS) for current and recalled prefracture status. Propensity score matching for age, sex, and deprivation in a 1:5 ratio was performed using patient level data from the Health Survey for England to obtain a control group for HRQoL comparison. The primary outcome was the difference in actual (TPF cohort) and expected (matched control) EQ-5D-3L score after TPF.Aims
Methods
Aims. The aims were to assess whether preoperative joint-specific function (JSF) and health-related quality of life (HRQoL) were associated with level of clinical frailty in patients waiting for a primary total hip arthroplasty (THA) or knee arthroplasty (KA). Methods. Patients waiting for a THA (n = 100) or KA (n = 100) for more than six months were prospectively recruited from the study centre. Overall,162 patients responded to the questionnaire (81 THA; 81 KA). Patient demographics, Oxford score, EuroQol five-dimension (EQ-5D) score, EuroQol visual analogue score (EQ-VAS), Rockwood Clinical Frailty Score (CFS), and time spent on the waiting list were collected. Results. There was a significant correlation between CFS and the Oxford score (THA r = −0.838; p < 0.001, KA r = −0.867; p < 0.001),
The COVID-19 pandemic has caused unprecedented disruption to elective orthopaedic services. The primary objective of this study was to examine changes in functional scores in patients awaiting total hip arthroplasty (THA), total knee arthroplasty (TKA), and unicompartmental knee arthroplasty (UKA). Secondary objectives were to investigate differences between these groups and identify those in a health state ‘worse than death’ (WTD). In this prospective cohort study, preoperative Oxford hip and knee scores (OHS/OKS) were recorded for patients added to a waiting list for THA, TKA, or UKA, during the initial eight months of the COVID-19 pandemic, and repeated at 14 months into the pandemic (mean interval nine months (SD 2.84)). EuroQoL five-dimension five-level health questionnaire (EQ-5D-5L) index scores were also calculated at this point in time, with a negative score representing a state WTD. OHS/OKS were analyzed over time and in relation to the EQ-5D-5L.Aims
Methods
Aims. The metabolic equivalent of task (MET) score examines patient performance in relation to energy expenditure before and after knee arthroplasty. This study assesses its use in a knee arthroplasty population in comparison with the widely used Oxford Knee Score (OKS) and EuroQol five-dimension index (EQ-5D), which are reported to be limited by ceiling effects. Methods. A total of 116 patients with OKS,
Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.Aims
Methods
