The team are building a nationwide and global reputation for outstanding Orthopaedic & Trauma clincial research
PROximal Fractures of the Humerus: Evaluation by Randomisation
This study looked at patients who had broken (fractured) the top end of their upper arm bone (humerus). These fractures are common in older people and in less serious cases, they are treated by supporting the arm in a sling to help the bone to heal. In about half of these fractures it is more serious and the patient requires surgery. However, for the majority of serious fractures surgeons are not sure whether an operation is better than supporting the arm in a sling and leaving the bone to heal. Therefore this study wanted to know which of these two treatments (sling or operation) was better for these more serious fractures.
This study looked at patients who had broken (fractured) their collarbone. Some fractures heal well but other fractures (displaced) require surgery as they may not heal by themselves. At this time no proper comparison had been done to scientifically prove whether surgery or non-operative treatment was better for these displaced fractures. The purpose of this study was to see if surgery improves healing and function compared to non-surgical treatment.
Platelet Rich Plasma in Achilles Tendon Healing
This study looked at patients who had ruptured their Achilles tendon (this connects your calf muscles to your heel bone). Standard treatment for these patients not requiring an operation is to place the ankle into a cast, splint or boot and allow the body to heal itself naturally. A new treatment has been developed using a sample of the patient’s blood and extracting the “platelet rich plasma” from it. This plasma contains special growth and regeneration factors that can be injected into the Achilles tendon. This method has been shown to accelerate healing in a small group of patients. PATH-2 looked at a larger group of patients to see whether this was an effective treatment.
UK Fixation of Distal Tibia Fractures
This study looked at investigating two different ways of fixing a broken shin bone (of the leg). For patients who have broken the lower part of their shin bone (distal tibia) there are several treatment options. Sometimes the broken bone can be held in a plaster cast. However, the majority of breaks require surgery. During surgery the bone is commonly fixed with a metal device which is under the skin. The device can sit inside the hollow part of the bone (a “nail”) or can sit on the surface of the bone (a “plate”). This study compared plates versus nails with regards to the time required for the bone to heal, ankle function and quality of life.
Intramedullary Nail versus sliding hip Screw Inter-Trochanteric Evaluation
This study looked at patients who had broken their hip and sustained a ‘Pertrochanteric fracture’. Pertrochanteric fractures are commonly treated with an operation where they “internally fix” the fracture. The two common methods of internal fixation are Gamma intramedullary nails and sliding hip screws. It is unknown whether nails have better outcomes than screws. This study compared these two types of operation.
This study looked at patients that had an isolated ulnar shaft fracture (a forearm fracture where only one of the forearm bones is broken). There are currently two treatment methods used across North America and Europe. The bones can be manipulated (closed reduction as the skin is not opened) to re-establish a normal position of the bones, followed by the application of a cast for 6 weeks. Another method is surgery; opening the skin and replacing the bone pieces under direct vision (open reduction) and maintains this with plate and screws. Research over the last 15 years has found inconclusive evidence to show which treatment works best. Therefore this study wanted to determine if surgery using a plate and screws will improve healing in an ulnar shaft fracture versus non-surgical treatment.
Wound management of Open Lower Limb Fractures
This study compared two different types of wound dressings for patients who had an open (exposed through the skin) fracture of the leg. Once the patient had surgery to clean the bones and fix them back into place their wound was covered in a sterile dressing. The research compared ‘standard dressing’ (sterile gauze with a traditional bandage) to ‘suction dressing’ (which also covers the wound with a sterile dressing but it is attached to a machine which gently ‘sucks’ on the dressing to remove any build-up of fluid).
Furlong Evolution® Hip Trial
This is a commercial study reviewing progress of patients who have undergone total hip replacement surgery using the Furlong short stem implant. The potential benefit for using a short stem implant is that it aids early mobilisations and preserves the femoral bone should further surgery be required.
Follow up of hip arthroplasty Long term: Effect on Revision
This is a study funded by the National Institute for Health Research the effectiveness of hip arthroplasty surveillance (long term follow-up). The primary objective is to investigate if there is a difference in the health related quality of life after hip revision surgery between patients diagnosed through routine surveillance and those who have not had any form of long term follow up.
Ankle Injury Rehabilitation
Principal Investigator: Mr Mike Kelly
This is a randomised controlled trial investigating two different treatments for patients who have broken their ankle. To keep the broken bones still and supported ankle fractures can be placed in plaster cast whilst the bones are healing. An alternative way to treat this injury is to using a functional brace or ‘walking boot’ which can be removed in order to move the ankle and perform exercises. Both treatments are successfully used in hospitals across the UK to treat ankle fractures.
The purpose of this study is to compare functional bracing ‘walking boot’ to plaster cast, to see which improves the quality of people’s lives more. It is important to carry out a study in which the two methods are compared so in the future individuals with similar injuries will receive the best possible treatment.
Coordinated by: University of Warwick Clinical Trials Unit
Funded by the Department of Health
Recruitment end date: September 2019
(R&I number: 4068)
A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESS
This is a commercial study involving patients who need shoulder replacement surgery. It involves reviewing the progress of patient who have a LIMA stemless total shoulder replacement. Having a stemless implant preserves the bone stock in the upper arm bone (humerus) should further surgery be required. This can be anatomical or reverse arthroplasty.
Recruitment end date: Sept 2019
(R&I number: 3650)
Total Ankle Replacement Versus Arthrodesis (TARVA) Study
The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis (ankle fusion) in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments
Funded by: National Institute for Health Research
Recruitment End Date: December 2018
(R&I number: 3521)
Distal Radius Acute Fracture Fixation Trial 2
Principal Investigator: Mr Tim Chesser
This is a randomised controlled trial investigating two different treatments for patients who have broken their wrist. The ‘distal radius’ is the largest of the bones that forms the wrist joint, some fractures of the distal radius can be treated in a plaster cast and do not require an operation. However, other fractures are ‘displaced’ which means the bone has moved out of normal alignment and they need to be manipulated back into their original position. The manipulation can be painful therefore is carried out under local, regional or general anaesthetic. Following the manipulation, the bone fragments of displaced fractures need to be supported whilst they heal. The two techniques for holding the position of the bone fragments post manipulation are Moulded Plaster Cast and K- Wire fixation.
Moulded Plaster Cast: This technique involves the application of a plaster cast which is shaped (‘moulded’) over the skin to hold the bone fragments in position.
K-wire fixation: After the skin has been covered in antiseptic, sharp wires (K-wires) are passed through the skin over the back of the wrist and directly into the bone in order to hold the bone fragments in the correct position, a plaster cast is then applied but it is not specifically moulded.
The purpose of the trial is to compare the two different treatments by following patient outcomes through postal questionnaires to find out which is best for patients who have sustained a displaced fracture of the distal radius.
Coordinated by University of Oxford Clinical Trials
Funded by National Institute for Health Research
End Date: 01/04/2019
(R&I number: 3891)
STAR (Support and treatment after joint replacement)
STAR (Support and treatment after joint replacement)
Many people with severe knee pain because of osteoarthritis have a total knee replacement, which involves replacing the painful knee joint with an artificial joint. Over 75,000 total knee replacements are performed annually by the NHS and as the population continues to age numbers are expected to rise. People often find that they have pain in the first three months after surgery although most people get better. About 1 in 5 patients have ongoing pain after 3 months, we call this long-term pain.
The STAR trial: Evaluation of a care pathway for patients with long-term pain after knee replacement. Our proposed study is investigating a new best care pathway to see if it is of benefit to patients with long-term pain after knee replacement. We will recruit 380 patients with pain at 3 months after knee replacement from four hospitals in the UK. Two-thirds of patients will be randomly chosen to receive the STAR care pathway and one-third of patients will receive the usual care that their hospital provides. The STAR pathway involves a clinic appointment with a healthcare professional to better understand the possible causes of pain after knee replacement. People will then be referred to see relevant health professionals for treatment as needed, such as physiotherapists, orthopaedic surgeons, GPs, or pain specialists. We may decide that for some people the most appropriate course of action is to regularly monitor their pain, and then begin treatment if the pain worsens. We will ask everyone in the study to complete questionnaires after 6 months and 12 months to see if the STAR care pathway improves patients’ pain. We will also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if providing the STAR care pathway can improve patients’ outcomes after knee replacement and is good value for money to invest NHS resources.
This project is funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0613-20001). Due to be completed in 2020.