Research Studies
Current
The Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2).
The METEOR2 study is recruiting adults who still have knee pain and/or difficulty moving following cartilage surgery (meniscectomy). At present, there are several treatment options for treating ongoing pain following a meniscectomy, ranging from knee therapy (physiotherapy) to further surgery in the form of a ‘meniscal transplant’. Meniscal transplant is thought to provide cushioning to the joint surfaces and improve symptoms, however it has a long recovery period and the operation carries risk of surgery as well as not helping with symptoms. At present, it is not known whether the problem of ongoing pain following a meniscectomy is best treated with personalised knee therapy or surgery to replace the meniscus. Both treatments could improve pain and restrictions. Patients taking part in this study will either have meniscal transplant surgery or personalised knee therapy to see which method gives better clinical outcomes and is most cost effective and will be followed up for 24 months post randomisation. A total of 144 participants will be recruited across the UK and internationally, including Australia, Canada and Belgium.
This study is sponsored by the University of Warwick.
Funded by National Institute for Health Research – Health Technology Assessment programme.
Musgrave Park Hospital is currently open to recruitment.
Current
ODD SOCKS - Outcomes of Displaced Distal tibial fractures - Surgery Or Casts in KidS: A multi-centre prospective randomised superiority trial of conservative versus surgical treatment for displaced distal tibial fractures in children.
The ODD SOCKS study is comparing which is the best treatment for ankle fractures in children between 8 and 15 years old, surgery or cast. Broken ankles in children often involve the area from which the bone grows – the growth plate. Some doctors believe that children with growth plate injuries need surgery to reset the bones to ensure that the growth plate is restored into its original position. They believe that this will lower the chance of abnormal growth. Other doctors however believe that attempting to reset the bones to restore the growth plate with surgery could bring about further damage. These doctors recommend the bones are treated in a plaster cast, without surgery to reset the bones. Currently it is not known which treatment offers the best outcome due to the lack of high-quality scientific evidence. The ODD SOCKS study aims to find the best treatment, surgery or cast.
The ODDS SOCKS study will recruit 192 children from hospitals across the UK.
This study is sponsored by Alder Hey Children’s NHS Foundation Trust.
Funded by National Institute for Health Research – Health Technology Assessment programme.
The Royal Belfast Hospital for Sick Children will being opening for recruitment to this study soon.
Current
Bracing Adolescent Idiopathic Scoliosis (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis.
The aim of the BASIS study is to find out whether a night time brace is non-inferior to a full time brace in preventing curve progression to 50 degrees or more in children with Adolescent Idiopathic Scoliosis before skeletal maturity, but superior in terms of patient quality of life and acceptability. Currently children and young people diagnosed with adolescent idiopathic scoliosis often need to wear a full-time brace to try and treat the curve to the spine, which means wearing the brace for most of the day. This study is looking at a different type of back brace to that used in the UK, a brace worn only at night time. The night time brace is currently used in other countries in the world, although before it can be used routinely in the UK, it needs to be confirmed whether it is as good as the standard brace that is worn for most of the day.
The study aims to recruit 780 children aged 10 -15 years with a diagnosis of adolescent idiopathic scoliosis.
This study is sponsored by the Sheffield Children’s Hospital.
Funded by National Institute for Health Research – Health Technology Assessment programme.
Musgrave Park Hospital is currently open to recruitment.
(The BASIS Study – The BASIS Study is trying to find out which type of back brace is best for treating children and young people with scoliosis.)
Current
Imaging in Paediatric Osteomyelitis (the PICBONE study): a multi-centre cohort study to understand the role of MRI and Ultrasound in the diagnosis of acute haematogenous osteomyelitis in children.
The PIC Bone Study is recruiting children aged between 0-15 years from hospitals across the UK to find out the best way to identify bone and joint infections in children. When a child is brought to the emergency department with a painful limb without an obvious injury, doctors are typically faced with a dilemma between two diagnoses: a serious, though relatively uncommon, infection of their bones or joints OR a non-serious, though common, temporary swelling to their joints. Telling these apart is often not easy and due to the seriousness of infection, this must been done quickly which can be challenging. Often the use of ultrasound and MRI scans are required to diagnose bone and joint infections, but it is not known which one is best.
The PIC Bone Study aims to find out which tests spot infections most quickly and accurately in order to create a pathway that doctors and nurses can use in emergency departments to aid the diagnosis of bone and joint infections.
This study is sponsored by the University of Oxford.
Funded by National Institute for Health Research – Health Technology Assessment programme.
The Royal Belfast Hospital for Sick Children will being opening for recruitment to this study soon.
Current
Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI): a multi-centre, pragmatic, parallel group, superiority randomised controlled trial.
The RAPSODI-UK study compares two types of shoulder replacement: the Total Shoulder (Anatomic) replacement, and the Reverse Shoulder replacement. These shoulder replacements are the most commonly used in the UK for patients with shoulder arthritis.
They both help to reduce pain and maintain or improve movement however, doctors genuinely don’t know yet which one works best and the aim of the study is to find this out.
The RAPSODI-UK study aims to recruit 430 patients aged 60 years and over with painful osteoarthritis of the shoulder and in intact rotator cuff. A number of hospitals across the UK are participating in this study.
This study is sponsored by the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust.
Funded by National Institute for Health Research – Health Technology Assessment programme.
Musgrave Park Hospital is currently open to recruitment.
Current
SarcoSIGHT: A Randomised-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care.
The SarcoSIGHT study will recruit 500 patients to compare two different surgical techniques that are currently used in the NHS for sarcoma surgery. With sarcoma it is important to remove all the tumour and not leave any behind. This can be difficult, because these tumours can be large and deep in the body, which means small amounts of tumour are sometimes missed. During the standard procedure, surgeons use scans taken before the operation to guide them during the operation. Fluorescence guided surgery is a new technique in which a dye is given to patients the day before their surgery. The dye is infused directly into the patient’s veins by inserting a needle attached to a thin tube and releasing the dye into the tube in a short procedure. The infused dye collects in the tumour. During the operation this dye might help the surgeon to see the tumour better when it is viewed through a special camera using infra-red light. Patients recruited to the study will be allocated to have either the standard surgery or the new technique of fluorescence guided surgery. The study will provide more information on which technique is better at removing the whole tumour, which will improve future patient care.
This study is sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.
Funded by National Institute for Health and Care Research – Efficacy and Mechanism Evaluation programme.
Musgrave Park Hospital will being opening for recruitment to this study soon.
Current
PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations: The PERISCOPE trial.
The aim of the PERISCOPE study is to find out how best to treat patients with inflammatory arthritis who are about to have orthopaedic surgery. In recent years, special immune-suppressing medicines, called biologics, have been developed, which are very effective in controlling the arthritis disease process and symptoms but can increase the risk of some infections. Currently these medications are stopped prior to surgery but there are no randomised trials to support this. In the PERISCOPE study, patients will be randomly assigned to either stopping or continuing their biologics before orthopaedic surgery. Researchers will then follow patients for up to 12 months to check their health and wellbeing to find out whether it is better to stop or remain on this medication.
The aim is to determine whether it is better to continue or stop biologics medication. Belfast is one of many sites across the UK taking part in the study which will recruit 394 participants.
This study is sponsored by the University of Leeds.
Funded by National Institute for Health Research – Health Technology Assessment programme.
Musgrave Park Hospital is currently open to recruitment.
Current
Study of Retrieved Orthopaedic Implants and Associated Tissues and Data.
Orthopaedic surgery to remove a diseased/damaged joint and replace it with an artificial one has been shown to decrease pain and improve mobility, function, and psychosocial wellbeing. However, for a number of different reasons the artificial joint sometimes then needs to be removed and replaced with a new one. Devices such as artificial joint replacements that have been surgically removed as part of a patient’s ongoing clinical care and treatment are called explants. Explants, and any additional data associated with the explant, are of interest to researchers because they can help improve the knowledge and understanding of the device’s performance and why they needed to be removed. Explant research is also used to help develop and improve current methods for testing new orthopaedic devices in the laboratory.
The Orthopaedic Retrievals study aims to help improve the knowledge and understanding of how well artificial joint replacements perform while in the body and also why they sometimes need to be removed.
This study is sponsored by the University of Leeds.
Funded by National Institute for Health Research and the Engineering and Physical Sciences Research Council.
Belfast are currently open to recruitment.
Current
World Hip Trauma Evaluation (WHiTE ) Platform A framework for clinical trials for fragility hip fractures in those aged 60 and over Appendix 10 to WHiTE Platform –LIT Lidocaine intravenous trial -CTIMP comparison.
Every year around 70,000 people in the UK break their hip and around a quarter of these patients have an episode of ‘delirium’ after their surgery. Delirium is a condition where the patient loses awareness of themselves and their environment, and has difficulty thinking clearly. For relatives and friends, as well as the patient, delirium can be very distressing. The symptoms of delirium are similar to those of patients with dementia but develop over a short period and tend to vary over time. Most patients suffering with delirium recover quite quickly, but delirium can result in longer hospital stays and a greater risk of complications. Delirium is also associated with an increased risk of developing dementia in later life. Inflammation, caused by the hip fracture and by the surgery to repair the hip, is thought to be the root cause of delirium. This study will investigate if giving a drug called ‘lidocaine’ during surgery has an effect on delirium symptoms in the immediate post-operative period and on the development of cognitive impairment, quality of life and mortality in the following year.
This study is sponsored by the University of Oxford.
Funded by National Institute for Health Research – Patient Benefit programme.
This study is now closed to recruitment within the Belfast Health and Social Care Trust.
Current
World Hip Trauma Evaluation (WHiTE ) Platform A framework for clinical trials for fragility hip fractures in those aged 60 and over Appendix 12 to WHiTE Platform -DUALITY Dual mobility versus standard articulation total hip replacement in the treatment of older adults with a hip fracture.
Every year around 70,000 people in the UK break their hip. Hip fractures are a common and very serious injury in older people. The DUALITY study is comparing two treatments for one specific type of hip fracture. Currently, surgeons use one of two types of total hip replacement, which is an operation to replace both the ball and socket of the hip joint. One type uses a small ball within the socket (standard), in the other the ball is enclosed within a larger plastic ball (dual mobility). This study will investigate which of these treatments gives a better result for people aged 65 years and over with a hip fracture from hospitals across the UK, looking at complications after surgery, particularly dislocation.
This study is sponsored by the University of Oxford.
Funded by National Institute for Health Research – Patient Benefit programme.
This study is now closed to recruitment.
Current
Can the use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty with Spinal Anaesthesia? – A Pilot Study.
The Virtual Reality (VR) study aims to determine the feasibility of using VR during total knee replacement with spinal anaesthesia and to investigate what outcomes, if any, can be influenced by using VR.
All patients recruited to the study will receive spinal anaesthesia. However, half of the patients will receive VR and a light level of sedation, whilst the other half will not receive VR but will receive a deeper level of sedation (standard of care). When using VR during knee replacement, it is expected that a lighter level of sedation would be required. This could help to reduce the side effects of sedation and aid quicker patient recovery. This pilot study be able to investigate this further. The outcomes of the VR study will be tested in order to help choose which outcome is the most appropriate to use if undertaking a larger study.
This small study aims to recruit 40 patients, aged 18 and over having a total knee replacement.
This study is sponsored by the Belfast Health and Social Care Trust.
Funded by Trauma and Orthopaedics Research Charity.
Musgrave Park Hospital will being opening for recruitment to this study soon.
Current
A randomised controlled trial comparing gait in fixed (Triathlon® condylar stabilised knee, Stryker, Mahwah, NJ) or rotating (Attune® Rotating Platform, DePuy Synthes Joint Reconstruction, Warsaw, IN, USA) cementless total knee arthroplasties.
Having a knee replacement is a major operation. There are many different types of knee implants which can be used for this surgery. Newer implants or design features are introduced on a regular basis in an attempt to improve patient outcomes. We are particularly interested in two types of knee replacements, Triathlon and Attune. The first Triathlon knee was implanted in 2004 and the first Attune knee in 2013. To date, both implants have had good patient outcomes and longevity. Currently there is only a small amount of literature available on the Attune knee as it is still a relatively new implant. Worldwide, the Triathlon is widely used and is also a well-established, successful implant used in Musgrave Park Hospital. The G-FORCE study will help to determine whether the Attune can improve patient outcomes by comparing the patient’s gait, by walking on a treadmill, and look at a range of patient outcome scores to assess function, how much their knee can bend and straighten and the rate of complications for the Attune and Triathlon knees. These outcomes will be assessed before their knee replacement and up to a period of 1 year following their surgery.
This study is sponsored by the Belfast Health and Social Care Trust.
Funded by Trauma and Orthopaedics Research Charity Northern Ireland and DePuy Synthes.
Musgrave Park Hospital will being opening for recruitment to this study soon.
Past
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.
The HUSH study aims to directly compare two methods of treating fractures of the humeral shaft, to find out whether arm function and quality of life in patients with this fracture is better with the more conservative cast-and-brace treatment, or with surgery. There appears to be a worldwide trend towards treating these fractures with surgery (rather than cast and brace), however there is no high quality evidence to support this. Various reviews of the current evidence have recognised the need for further trials in this area. Surgery is the more expensive route, and has a higher risk of complications 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. The trial will also compare the cost effectiveness of both approaches. The trial aims to produce sound evidence to establish if the drawbacks of surgery are balanced by improved results and acceptable costs.
The study recruited 334 patients from various hospitals across the UK including the Royal Victoria Hospital in Belfast.
This study is sponsored by the University of Oxford.
Funded by National Institute for Health Research – Health Technology Assessment programme.
This study is now closed to recruitment.
Past
Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows. A multi-centre prospective randomised superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus in children.
Broken bones of the elbow are common in children. The SCIENCE Study aims to improve the treatment of children who have a particular type of elbow break, called a ‘medial epicondyle fracture’. Currently surgeons have varying opinions about the best treatment for this type of fracture in children. Some surgeons argue that these breaks should be treated with surgery to fix the bone with wires or screws, whilst others argue that treating the bone in a cast will give just as good results but without the risks and scars associated with surgery. This means that the treatment that children receive may depend on the beliefs and understanding of the surgeon, rather than proper science.
A total of 334 patients, aged between 7 and 15 years, were recruited to the study, with 68 sites open to recruit patients across United Kingdom, Australia and New Zealand. The Royal Belfast Hospital for Sick Children were the top recruiting site for the study with a total of 29 patients.
This study is sponsored by the University of Oxford.
Funded by National Institute for Health Research – Health Technology Assessment programme.
This study is now closed to recruitment.
Past
Weight Bearing in Ankle Fractures. A randomised clinical trial of weight-bearing following operatively treated ankle fracture.
The WAX study recruited 561 patients, aged 18 years and older, who required an operation for an ankle fracture. Patients were recruited from several centres across the UK including the Royal Victoria Hospital and Craigavon Area Hospital. Patients were randomly allocated to either weight-bear early (2 weeks following surgery) or to delay weight-bearing (6 weeks following surgery).
The study aimed to investigate the clinical and cost effectiveness between the two treatment groups.
The Royal Victoria Hospital Children were the 2nd highest recruiting site for the study with 61 patients.
This study was sponsored by the University of Oxford.
Funded by National Institute for Health Research – Patient Benefit programme.
This study is now finished.
To read the results of this study please visit the link below for more information.
Past
Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total hip arthroplasty: results of a randomized controlled trial (TRAC-24)
This study investigated using a drug called tranexamic acid to reduce blood loss in hip and knee replacements. Normally this drug wasn’t used in high-risk patients but is given to low risk patients by injection at the time of surgery.
In our study we included high risk patients but in addition we looked at giving it in tablet form the first 24 hours after the operation. Having a lower blood loss reduces your risk of needing a blood transfusion and increases your exercise capacity. This makes recovery easier and can reduce the strain on your heart.
The study found that the addition of the tablets after knee replacement significantly reduced blood loss which led to a shorter stay in hospital. This led to a change in practice for patients in Musgrave Park Hospital. We found no difference in blood loss when we gave the additional tablets for hip replacement patients.
This was a ground-breaking study as it was the first orthopaedic randomised controlled trial with tranexamic acid to include high-risk patients and we saw no increase in any problems in the patients that were given the drug meaning that it is safe to use in high-risk patients.
This work was jointly funded by Trauma & Orthopaedics Research Charity and the Public Health Agency R&D.