Clinical trials

The Evaluating PREP Study aims to determine in whether the PREP Programme has an impact on clinical outcomes for Veterans undergoing TKR. Specifically, we are exploring whether prehabilitation and a week long intense individualised rehabilitation period after TKR surgery has a positive impact on functional and mental outcomes, and whether these are sustained for up to 12 months post-surgery.

Observational study to assess the effectiveness of cell therapy for the treatment of osteoarthritis

Patients who underwent Total elbow replacement from and after 2010 with a minimum of 6 months at a single institution will be studied retrospectively. The data required for the study will be collected prospectively. Patient demographic data will be collected through the Information team and electronic patient record. Surveys will include questions about whether they recalled the activities that were not recommended by the surgeons, oxford elbow scores and the type of activities they currently perform. Patients will be contacted by telephone after initial screening against inclusion and exclusion criteria, and subsequent questionnaires will be sent through post or by email, whichever the patient prefers. Patients who do not respond to the postal or email questionnaire will be contacted again by telephone.

This is a single-site, observational pilot study that aims to understand whether there is a biological explanation for why some patients with anxiety or depression experience poorer outcomes after total knee or hip replacement surgery. The study investigates the role of inflammation inside the joint, using tissue, fluid, and blood samples collected during routine care, alongside patient-reported outcome questionnaires. Study Design and Hypothesis The hypothesis is that patients with pre-existing anxiety or depression will show more inflammation in their joint tissue or blood, and that this may be linked to poorer functional outcomes after surgery. An alternative explanation is that these patients may report worse outcomes without an identifiable biological cause. The study does not involve any trial drugs or new treatments and does not use a placebo or randomisation. Patients will be grouped based on whether or not they meet the criteria for anxiety and/or depression as measured by two validated mental health screening tools: GAD-7 (for anxiety) PHQ-8 (for depression) Sampling and Participant Involvement: The plan is to include 56 patients, equally split between hip and knee replacement groups, and between those with and without anxiety/depression (14 per subgroup). Participants will be identified by the clinical research team from the waiting lists of two lead surgeons and approached by post and phone before their routine preoperative assessment clinic. At that appointment, consent will be obtained and the participant will complete baseline questionnaires. The same questionnaires will be repeated at 3 and 6 months postoperatively. No additional visits will be required. Study Procedures and Timeline 1. Preoperative phase (routine clinic visit): Participants are posted a cover letter, patient information sheet, and consent form ahead of their clinic visit. A member of the research team calls the patient to explain the study. At the clinic, a research nurse obtains informed consent. Participants complete baseline questionnaires assessing pain, quality of life, and mental wellbeing (e.g. Oxford score, EQ-5D, PHQ-8, GAD-7). 2. Day of surgery: An additional 20 ml of blood is collected at the same time as routine preoperative blood tests, using the same venepuncture. While under anaesthetic, the operating surgeon collects small tissue samples (synovial fluid, synovial tissue, and fat) from the joint. These samples are normally discarded as part of the operation. Samples are anonymised and sent to pathology and research laboratories for analysis. 3. Postoperative follow-up: At the 3-month clinic visit (routine care), participants complete the same questionnaires and provide a further blood sample of approximately 15 ml. At 6 months, questionnaires are completed remotely via the MyRecovery app, with no further hospital visit or samples required. All study procedures are aligned with routine NHS care to minimise burden. There are no additional clinic visits required. Data Handling and Analysis The study will compare inflammation levels (in blood and tissue) between groups and analyse how these relate to patient-reported outcomes. All data will be anonymised. Blood samples will be processed at local NHS labs (Shrewsbury) and at a specialist centre in Sheffield for specific inflammatory markers (e.g. IL-6, CD solubles). Synovial tissue will be histologically analysed on-site for synovitis.

This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.

The aim of this study is to determine the prevalence of complications including PUs at time of admission to a regional spinal injury rehabilitation unit (MCSI), the relationship between wait time to admission for specialist SCI rehabilitation and complication n occurrence, neurological recovery, and length of stay. The hypothesis is that wait time to transfer from the acute hospital to the specialised SCI rehabilitation unit is associated with increased PU prevalence and other SCI complications, as well as poorer neurological recovery and increased length of stay.

Osteoporosis is a chronic condition characterised by reduced bone mass and microarchitectural deterioration of bone tissue leading to fracture. One in two adult women and one in five men will sustain a fragility fracture in their lifetime. The fractures caused by osteoporosis are a leading cause of morbidity and mortality. Optimising bone health and prevention of fracture is the best management strategy and requires detection and correction of any risk factors associated with fracture. Multiple studies have established clinical risk factors associated with fracture, including low bone mineral density (BMD), lifestyle factors such as smoking and excessive alcohol intake, a parental history of hip fracture, and glucocorticoid use, among others. The incorporation of these clinical risk factors with BMD using the well validated Fracture Risk Assessment Tool (FRAX) over the last two decades has significantly improved fracture risk prediction. Nonetheless, BMD and FRAX have limitations, and many patients continue to experience fractures despite having normal or elevated BMD and no identifiable FRAX elements. Additionally, FRAX does not utilise any biomarkers, many of which may have a significant role in fracture risk. Beyond the traditional well-established clinical risk factors incorporated into FRAX, new comorbidities have emerged in recent years as important determinants of bone strength and susceptibility to fracture. Obesity, type II diabetes, sarcopenia (age related progressive loss of muscle tissue), and frailty are global pandemics and have been increasingly linked with fracture risk. On the case of obesity, for example, there has been an increasing debate whether obese patients are at higher or lower risk for fracture. Whilst Body Mass Index (BMI) remains the most widely used measure of obesity, BMI is not a direct measurement of central obesity which is better assessed by waist circumference, percentage body fat measured by whole body areal bone mineral density (BMD), or visceral fat area measured by computed tomography (CT). In 2023, the National Institute for Health and Care Excellence (NICE) recommended the measurement of waist to height ratio (WHtR) as a practical estimate of central adiposity with a ratio of ≥ 0.6 as a cut-off for high central adiposity. Waist circumference was introduced in the metabolic bone unit at the Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH) as a routine clinical measurement in 2023 following NICE recommendation. In addition to obesity, clinical frailty measured by the Rockwood Clinical Frailty Scale, sarcopenia which is a state of reduced muscle power and declined muscle function, and type 2 diabetes are all variables that can be easily collected in routine clinical practice and are likely to play significant roles in numerous health outcomes including ageing, fracture, and mortality. Along with routine measurements, taken as standard of care, we also plan to utilise some of the latest scientific techniques and research into metabolomics and microbiome studies in subgroups of our patients. Further research is urgently needed in these areas to further the osteoporosis field and benefit patients at risk of fracture. The metabolic bone service at RJAH is one of the largest metabolic services in the UK in terms of patient numbers and our service continues to experience a significant growth in demand. We have a considerable amount of data collected from patients attending the metabolic clinic and bone density unit over many years. We have a track record of successfully using patient data, anonymously, to enhance our knowledge of bone health and the risk factors of fracture to optimise treatment for our patients through well designed research studies. We have previously assessed the use of bone markers for monitoring treatment, found relationships between levels of hormone therapy and bone density, levels of hormones on bone markers and serious side effects of bisphosphonate treatment.

It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that. The aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.

Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.

1. To assess the clinical utility of trabecular bone score (TBS) on fracture risk prediction including the new version (TBS V4) and future TBS versions at the spine and hip. 2. To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy. 3. To compare TBS to other imaging modalities of bone structure such as quantitative computed tomography (QCT) in fracture risk prediction and response to osteoporosis therapy.

This is a single-site trial, and it has been designed to compare a revision hip cohort with a revision knee cohort. All consecutive eligible patients, under the care of participating Co-Investigator Orthopaedic Surgeons, are approached for recruitment into the study. Eligible patients wishing to participate must require either revision hip or revision knee surgery and consent to be randomised to either NPWT PICO dressing for 7-day therapy (PICO 7) or NPWT PICO 14-day therapy (PICO 14). 82 Revision Hips and 82 Revision Knee participants, with 41\* of each cohort randomised to either a 7-day or a 14-day NPWT dressing treatment duration period. The 7-day cohort will be treated with PICO7 dressings and pumps, and the 14-day cohort will be treated with PICO14 dressings. \*Randomisation will be stratified, so it will continue until there are at least 41 participants in each cohort.

The study will use data already obtained through the metabolic clinical service to improve diagnosis and management of our patients.