Open studies

A Randomised Controlled Trial of Scaffold InSertion and MIcrofracture Compared to Microfracture Alone for the Treatment of Chondral or Osteochondral Defects of the Knee: The SISMIC Study

Knee injuries are common and can lead to pain and disability. Injuries to the smooth cartilage that lines the ends of the bone in joints can cause ongoing problems as the cartilage does not have a blood supply and rarely heals once injured. 10,000 people a year in the UK have a severe articular cartilage injury that warrants surgical treatment. One way to treat this is to try to repair or restore the cartilage in the damaged area. Cartilage does not grow back on its own, so an operation known as “microfracture” can be performed to encourage the cartilage to grow. A surgical tool is used to make perforations in the bone in the damaged area which allows blood and bone marrow to seep out of the holes, encouraging healing. A “scaffold”, which is usually made of the same material that makes up most of the cartilage (collagen), can be added, termed Autologous Matrix-Induced Chondrogenesis (AMIC). The scaffold is secured in place and acts as a template for new cartilage to form on. It is not clear if using a scaffold improves the outcome for patients. Using scaffold makes the operation more complex (approximately 20 minutes longer) and the cost of the scaffold is approximately £900, so it is important to establish if adding a scaffold results in a better outcome for patients and is cost-effective for the NHS. The study will find out whether adding the scaffold is worthwhile or not for patients with knee articular cartilage injuries.

We aim to recruit 176 patients, who will be randomised into two equal sized groups. One group of patients will have microfracture alone and the other will have microfracture plus scaffold (AMIC). Both groups will be followed for 2 years to collection information about quality of life, symptoms and pain in the knee, complications of surgery, need for further surgery and costs to the NHS and patients.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

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.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

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.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

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.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

Working with the NIHRBR, we are proposing to develop a centralised national recallable bioresource of 24,000 patients and relatives of patients with one or more of a spectrum of disorders which comprise immune-mediated inflammatory diseases (IMIDs), to support scientific and clinical IMID research.
1. DNA and serum + clinical and genetic data from 24,000 IMID patients and relatives recruited England-wide stored in a central biorepository funded by NIHR BioResource
2. Stratify participants into core datasets for analysis
3. Recallability – run by NIHRBR National Co-ordinating Centre, allowing patients stratified by clinical subtype or comorbidities to be recruited for future scientific or clinical trials (with additional approvals and consent)
Immune-mediated inflammatory diseases (IMIDs) are a spectrum of disorders with shared susceptibility genes, overlapping ways in which the immune response is developed, clinical features and comorbidities. However each disease also has unique disease-specific pathways in which they develop. Some treatments are effective against all these diseases, however others are not and can paradoxically make the condition worse. Learning about how these mechanisms work will help to target effective therapies to each specific disease area.

IMID BioResource will focus on 3 pivotal IMIDs and 3 cross-cutting co-morbidities:
• Rheumatoid Arthritis (RA)
• Psoriasis (and the linked seronegative spondyloarthropathies family)
• SLE and related syndromes: mixed and undifferentiated connective tissue diseases (MCTD and UCTD)
Cross-cutting co-morbidity phenotypes will initially focus on
• Chronic lung disease including COPD and Interstitial lung disease (ILD)
• Cardiovascular disease (CVD)
• Fatigue/mood disorders

The NIHRBR-IMID will be managed by a partnership across the 3 Northern Biomedical Research Centres (BRCs) (Manchester, Newcastle and Leeds) and co-ordinated from Manchester BRC. NIHRBR-IMID reflects common and overlapping areas in which all three partners demonstrate (inter)national leadership and expertise. Strategically NIHRBR-IMID will complement and synergise with existing BioResource supported diseases including a number of Rare Diseases.

Studies in follow up

The effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach; a randomised controlled trial: HemiSPAIRE

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.

Closed to recruitment – in follow up.

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