Open studies

Acute rehabilitation following traumatic anterior shoulder dislocation. Summary: Shoulder dislocations occur when the upper end of the arm bone is forced out of its joint socket because of a traumatic event. It is common and results in pain, disability and decreased function. Currently in the UK, some hospitals offer a single session of advice and some offer a course of physiotherapy. The UK guidelines currently say a course of physiotherapy ‘may be helpful’; whilst other national guidelines say advice alone is needed. We plan to perform a study across 30 UK hospitals to compare a single session of advice versus a course of physiotherapy for patients who have dislocated their shoulder. All adult patients with a dislocated shoulder managed without an operation will be screened. All participants who are eligible and consent to take part will be allocated by chance to either a single session of advice or the same session followed by a course of physiotherapy, across 30 UK hospitals, including 478 participants part. Both treatments are widely used, and clinical teams across the UK will be familiar with both. The primary aim is to compare the two treatment groups for differences in the Oxford Shoulder Instability Score six months after injury. This score measures function from the patients’ perspective. Improvements in functional outcome and quality of life as well as complications and resource use will be collected at six weeks, three, six and 12 months after taking part in the study. The results are planned to be presented at national conferences, published in high quality journals and social media outlets. Lay team members will be supported to produce lay summaries of the research to be disseminated across the trial sites and individual trial participants.

Aim of study: To compare two ways of performing partial hip replacement to see which one allows patients to mobilise better and gives patients improved function after surgery. The best approach is more likely to allow patients to maintain their independence and return to their own homes after their injury.

Background: When someone breaks their hip they often need a partial hip replacement, also known as hemiarthroplasty. To perform this operation surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently, clinical guidelines suggest that this operation should be performed using a technique which involves cutting muscles and tendons from the side of the hip. This is called the lateral approach. Alternatively, a newer, modified technique can be used leaving all the major muscles intact and this may cause fewer problems for the patient. There is no research evidence to prove which approach is more beneficial. Patients and carers looking for information about this are likely to become confused by the many opinions of surgeons speaking about preferred techniques. It is therefore important to find out which technique is better for patients, based on research rather than opinion.

Study design: We will randomly allocate patients who agree to be part of the study to have one of the two techniques to partial hip replacement. We can then compare the impact of the two techniques on how quickly and fully patients mobilise, the level of pain they experience, and the safety of the techniques. We will also contact a number of patients from both treatment groups to discuss their experience of the surgery in more detail.

Patient and public involvement: This study was inspired by patients who said that mobility and speed to regaining independence are the most important outcomes after surgery. Patients and carers will continue to be involved throughout this study, to ensure that the study results are relevant and important to people at risk of breaking their hip.

Dissemination: We will publish the results of this study widely in scientific and other publications accessable to patients and all involved in the treatment of patients with hip fractures.

PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2 (PROFHER-2 Trial): A three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four-part fractures of the proximal humerus in older adults. Summary: This protocol describes a UK multi-centre three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four-part fractures of the proximal humerus in older adults.

Full title: In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention? The Fractured Ankle Management Evaluation (FAME) Trial.

Summary:

Background: Ankle fracture is one of the most common UK musculoskeletal injuries. Routinely, unstable fractures are treated with surgery to maintain the joint alignment whilst the fracture heals. However, for patients who experience complications after surgery, their loss of ankle function and quality-of-life is considerable. An alternative, non-surgical treatment is to apply a close contact cast (CCC); a plaster cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint. The key benefit of CCC is a reduced risk of the complications of surgery. The main potential risk of CCC is a loss of joint alignment with a consequent reduction in ankle function. CCC is a current evidence-based treatment in the UK for patients over 60.

Aim: This study aims to determine whether ankle function four months after treatment in younger adult patients with unstable ankle fractures treated with CCC is not worse than those treated with surgery, which is the current standard-of-care.

Design: This is a pragmatic, multicentre, randomised non-inferiority clinical trial with an embedded pilot study and will also involve analysis of health economics. A surveillance study using routinely collected data will be performed annually to five years.

Methods

890 Adult patients aged up to 60 with unstable ankle fractures will be approached for recruitment prior to their treatment and randomised to receive surgery or CCC in hospitals around the UK. Data regarding ankle function, quality-of-life, complications and costs will be collected at eight weeks, four and twelve months and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months after randomisation.

Impact

The 12 months results will be presented and published internationally and will inform the NICE ‘non-complex fracture’ recommendations in 2024. Five year long-term outcomes will be reported in 2027.

Full title: The HUmeral SHaft fracture trial: A multi-centre prospective randomised superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older

Summary: A humeral shaft fracture is a break in the long bone of the upper arm. It occurs mainly in two groups of individuals; young men and older women, as their bones are more fragile.  Currently, the most common treatment for these fractures is non-operative. Approximately 70% of cases are treated using a cast for two weeks and then a brace until the bone begins to heal properly – although there is large variation in treatments between and in hospitals. The risk of complications is low and the cost is also relatively low at £1,100. The disadvantages are that the patient is immobilised for a prolonged period and the cumbersome cast can lead to significant pain and discomfort in some patients. There is also a 20% chance that the break will not heal. This then requires surgery and involves additional costs of approximately £15,500.  There appears to be a worldwide trend towards treating these fractures with surgery (rather than a cast and a brace), however there is no high quality evidence that this is indeed a better option. Various reviews of the  current evidence have recognised the need for further trials. Surgery is the more expensive route, and has a higher risk of complication e.g. infection and nerve damage. However, there is a better chance of the bone healing successfully and the patient is likely to recover more quickly allowing them to regain their independence sooner.  Our aim is to directly compare these two methods of treating fractures of the humeral shaft. We want to find out whether arm function and quality of life in patient with this fracture is better with the more conservative cast-and-brace treatment, or with surgery. We also need to compare the cost effectiveness of both approaches. We want to produce sound evidence to establish if the drawbacks of surgery are balanced by improved results and acceptable costs.  The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon. Surgery will typically be followed by two weeks in a sling. Patients treated non-surgically will have a cast applied in the Emergency Department which they will use for two weeks. They will then change to a brace which is usually worn for a further 8-10 weeks. Both groups will be given a structured rehabilitation programme.  The trial will last for 12 months. Patients will be followed up at 6 months and 12 months after their injury.

Studies in follow up

Closed to recruitment – in follow up.

Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery