The Avon Orthopaedic Centre, based at North Bristol NHS Trust, has a long history of being one of the leading centres in the country for research and innovation in orthopaedic care.
The Bristol Medical School Musculoskeletal Research Unit are also based within the site, with this partnership enabling clinicians and research methodologists to closely collaborate both locally and internationally to deliver high quality research based on our multidisciplinary expertise.
Please speak to the person treating you to find out if there is a research study that may be able to help you.
An integral part of the Severn Major Trauma Network (SMTN) based at NBT, this highly skilled team are able to include patients in the crucial early phases post traumatic injury in a sensitive and caring manner.
Trauma & Orthopaedics Studies:
This study will explore if additional exercise advice for people aged 50 and over who have broken their wrist helps with recovery.
After breaking their wrist, people are often provided with basic advice by the person who is treating them about how to get their wrist working again. WISE would like to find out if more detailed exercise advice given by a Physiotherapist will improve how quickly and how well they recover from a broken wrist.
PI: Mr Alasdair Bott
Start Date: Mar 2024
End Date: Feb 2025
Local Ref: 5452
This study aims to find out the best treatment for patients with repeated dislocations of their kneecap (patella). The study is comparing personalised knee therapy, delivered by a Physiotherapist, to surgical stabilisation for improving patient function following repeated dislocation.
PI: Mr Damian Clark
Start Date: Dec 2023
End Date: Aug 2025
Local Ref: 5440
WHITE 15 – INITIATE
Following surgery for a hip fracture (broken hip) hospitals aim to help patients out of bed within 48 hours of surgery. Patients should also receive a minimum of 2 hours of rehabilitation per week. Patients who receive more than this seem to recover quicker and return home sooner. This study aims to find out if increasing the level of ward-based mobilisation activities for patients following hip fractures allows them to return home sooner.
PI: Kirsty Derrick
Start Date: May 2024
End Date: TBC
Local Ref: 5285
FIRST: Prospecive randomosied controlled trial comparing three splints for finger flexor tendon repairs, in patients over the age of 16.*
Following flexor tendon repair surgery, all patients are provided with a custom-made splint, which is moulded by a hand therapist in a clinic. The purpose of the splint is to protect the newly repaired flexor tendon. Currently, there are 3 different splints used in the NHS and the use of these splints varies in hospitals across the UK. It is known which splint is the best for the patient.
The FIRST study is comparing the three splints that are used in the NHS for patients who are having rehabilitation following flexor tendon repair surgery. We would like to know whether any of the three splints is better at getting patients back to their normal hand use. We would also like to find out what it is like to wear each splint, if patient swear their splints, and whether one splint is better value for money.
Principal investigator: Ruth Halliday
Start date: April 2023
End date: Nov 2024
White 12 Duallity: 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, similar in impact to a major stroke. We will investigate 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, in the other the ball is enclosed within a larger plastic ball; we do not know which is the better treatment.
We will investigate which of these treatments gives a better result for people aged 65 years and over with a hip fracture.
Principal investigator: William Poole.
Start date: April 2023
End date: Nov 24
Local ref: 5372
DRAFT 3-CASP: Distal Radius Acute Fracture 3: Cast verus Splint; a randomised non-inferiority trial comparing clinical and cost-effectiveness of a standard cast versus removable splint in Adults with a distal fracture tat does not require Manipulation. *
When a person breaks their wrist, the treatment usually involves a support for the injured wrist. This support provides pain relief. It also protects the fracture (the break) whilst it heals.
In most hospitals in the UK, people with a broken wrist are given a plaster cast. After 4 to 6 weeks, they go back to hospital to have the cast taken off.
The results of a recent research study show that a removable wrist splint might provide the wrist with the same amount of support as a cast.
The benefit of this is that you can take it off yourself at home, so you don’t need to have it removed at a hospital. This could be more convenient for you. Providing people with a splint instead of a cast might also save money for the NHS.
At the moment, doctors, physiotherapists and other healthcare professionals are not completely sure if having a splint gives the same level of pain relief and support as a cast.
In this study, we will directly compare people receiving a cast with people receiving a splint for treating broken wrists. We want to find out if levels of pain and the ability to do everyday tasks are similar between the two groups. We will also have a look at the cost of both treatment options to the NHS, and society as a whole.
Start date: 03/2023
End date: 12/2024
Local ref: 5350
AFTER: Ankle Fracture Treatment: Enhancing Rehabilitation*
After a broken ankle, the lower leg is usually placed in a cast or boot for a number of weeks so the broken bone can heal. When the cast or boot is removed the ankle initially feels stiff and sore. At this time, patients are given advice by health professionals on how to gradually get back to their usual activities and are given exercises to do at home.
In some hospitals, patients are asked to attend physiotherapy sessions. In other hospitals, patients will just receive advice. There is currently no scientific evidence showing that seeing a physiotherapist after an ankle fracture improves recovery. As physiotherapy appointments aren’t always convenient for patients, and because it’s important to make the best use of NHS time and resources, we want to find out if attending physiotherapy after an ankle fracture really does help improve recovery.
In the AFTER study, all participants will receive high quality information that will guide them with their recovery, with half of the participants also being asked to attend 4-6 physiotherapy sessions. Information on how quickly and how well patients are able to return to the majority of their usual activities will be used to make a comparison between the two treatments.
The AFTER study has been developed by patients and healthcare professionals, including physiotherapists and doctors. Their experience and knowledge have been used to plan this study which could provide an answer as to what type of rehabilitation is best.
Principal Investigator: Andy Riddick
Planned End Date: July 2024
Local ref: 5215
WHiTE 10 LIT : Lidocaine Intravenous Trial*
A broken hip is a very serious injury that requires surgery to repair or replace the broken bone followed by a period of recovery in hospital. Around a quarter of patients who have a hip fracture have an episode of ‘delirium’ following surgery. Delirium is a condition where the patient loses awareness of themselves and the environment, and has difficulty thinking clearly. 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 investigates the use of a drug called ‘lidocaine’ to see if it reduces the risk of delirium during surgery for a hip fracture.
Principal Investigator: Dr Paddy Morgan
Planned end date: June 2025
Local Ref: 5120
Rowtate: Randomised Controlled Trial of Specialist Vocational Rehabilitation and Psychological Support to Enhance Return to Work after Trauma.*
Getting back to work, voluntary work or education after an injury can be difficult. Many patients with serious injuries can have difficulties returning to work because of the physical and psychologists’ effects of problems. This can lead to financial and other problems. Overall, being in work is better for health than unemployment or prolonged sick leave. We therefore want to find out the best of healing patients make a successful return voluntary work or education. The Rowtate study aims to test the return-to-work programme support versus the standard trauma care at people returning to work after traumatic injury.
Principal Investigator: Edd Carlton
Planned end date:31/05/2024
Local Ref: 4927
HUSH: The Humeral Shaft Fracture Trial*
Fractures, or breaks, to the bone in the upper arm (Humerus) may either be treated with surgery to fix the broken bone with metal implants, such as plates & screws, or non-operative management in a brace or plaster. The aim of this study is to compare these two treatments to see if surgical or non-surgical treatment of these injuries provides patients with better function of their arm and quality of life.
Principal Investigator: Mr Alasdair Bott
Planned End Date: Feb 2025
Local Ref: 4852
FAME: The Fractured Ankle Management Evaluation*
Treatments for ankle fractures aim to keep the bones in the right position while the breaks in the bones heal. For more severe fractures treatment often involves an operation where cuts are made around the ankle, and plates and screws are fitted against the bone fragments to keep them in place. An alternative non-surgical treatment involves applying a snug plaster cast called a close contact cast, carefully shaped to the ankle, to hold the bones correctly while they heal.
This study will investigate whether the non-surgical treatment option will provide patients with comparable ankle function and quality of life to those treated with surgery.
Principal Investigator: Mr Mike Kelly
Planned End Date: 01/01/2027
Local Ref: 4607
ProFHER-2: PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2*
This study is investigating the best way to treat patients aged 65 and over who have broken the top end of the upper arm bone (humerus) near the shoulder where the bone is broken into more than two parts.
There are currently three commonly used treatment options for fractures of this kind, which are two types of joint replacement surgery or structured non-surgical treatment. It is currently not known what the ‘best’ treatment is so this study is comparing non-surgical treatment and two types of joint replacement; ‘hemiarthroplasty’ which involves replacing only the broken ‘ball’ of the joint (top end of the arm bone), or ‘Reverse Shoulder Arthroplasty’ which replaces both the ball and socket, but replaces the ball with a socket and the socket with a ball (hence ‘reverse’).
Principal Investigator: Mr Mark Crowther
Planned End Date: June 2025
Local Ref: 4202
WHITE 11: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions (FRUITI)*
Patients who sustain hip fractures that involve minimal displacement of the bone fragments may be treated surgically with either replacement of the hip joint of fixation of the fragments. The study is randomly allocating patients with these types of fracture to either type of surgery. Patients will be monitored up to 12 months post surgery.
Principal Investigator: Mr Tim Chesser
Planned End Date: 31/01/2029
Local Ref: 4695
Academic Orthopaedics Studies:
REST: A prospective randomised feasibility study assessing the impact of a tailored sleep intervention in patients undergoing total knee replacement
The aim of this research is to find out how best to design a randomised trial to test if we can improve sleep before knee replacement surgery and reduce long-term pain.
Knee replacement is the second most common operation in the UK with over 100,000 performed yearly. Around 20% of patients experience long-term pain after surgery causing problems with knee function, decreased activity, and a negative impact on wellbeing. Additional treatments and appointments needed to address long-term pain come at increased cost to the NHS. People with higher levels of pain before their operation are more likely to have long-term pain afterwards. Sleep has a two-way relationship with pain.
Reduced sleep causes increased pain and improvement of sleep has been shown to reduce both immediate and long-term pain in people with joint problems. Our aim is to find out how best to design a larger study to test a pre-operative sleep intervention for improving long-term pain. Patients on the surgical waiting list will be recruited and randomised to receive either standard care or the sleep intervention. Patients taking part in the intervention will attend a one-to-one appointment with an healthcare practitioner to assess their sleep issues and needs. They will then be given tailored sleep advice and will be assigned to one of 3 existing sleep interventions, cognitive-behavioural therapy for insomnia, relaxation, and mindfulness.
An interview study with practitioners and patients will explore acceptability of delivering the intervention and the feasibility of a full trial.
Principal Investigator: Nick Howells
Planned End Date: 31/08/2022
Local Ref: 4781
I-DECIDE: Making informed decisions before knee replacement: qualitative evidence base for a decision aid
Helping patients to make informed decisions about their surgery is central to good care. Knee replacement is a common elective procedure, but there is no decision aid to enable informed decisions about this surgery. This study will address this gap by providing evidence to underpin a future decision aid to improve informed decision-making about knee replacement.
Chief Investigator: Rachael Gooberman-Hill
Principal Investigator: Nick Howells
Planned End Date: 31/08/2023
Local Ref: 5069
Infection and Orthopaedic Management (INFORM): Mobilising evidence into practice
Between 2014 and 2020 we conducted the INFORM Programme to find out why some patients are prone to getting joint infections, how this affects patients, NHS resources, and to evaluate treatments. The randomised trial found that recovery was delayed in people receiving two operations, while people who only had one operation had better outcomes for pain, mobility, and quality of life up to a year after surgery, though these were similar at 18 months. NHS costs were lower when patients had one operation. We also found that conservative surgery (called debridement, antibiotics and implant retention, DAIR) performed within three weeks of infection has a far less negative impact on patients and clears infection in over 60% of cases. We will now put important findings from the programme into practice to improve patient outcomes and ensure that the NHS delivers the best possible care.
Chief Investigator: Andrew Moore
Planned End Date: 31/10/2023
Local Ref: 5069
JointPREP: A randomised controlled feasibility trial of a prehabilitation intervention in frail older people undergoing total hip or knee replacement
This study aims to see if we can improve recovery from surgery in older people having hip or knee replacements by giving them protein and asking them to exercise daily (according to ability) in the weeks before their operation. First, we want to see if people are willing to do this by running a small study. If they are, we will design a larger study to test whether it improves recovery.
Chief Investigator: Vikki Wylde
Principal Investigator: Mike Whitehouse
Planned End Date: 31/12/2023
Local Ref: 4999
PART: The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing. A pragmatic multicentre randomised controlled Trial with blinding.
Total knee replacement (TKR) is commonly used for treating severe arthritis, with over 100,000 performed annually in the UK. During TKR, surgeons can resurface the patella (replace the under surface of the kneecap with a plastic prosthesis) or leave the native patella to articulate with the femoral implant. Resurfacing the patella is initially more expensive (longer theatre time, higher implant cost, risk of additional post-operative complications), but in the long-term it can reduce the risk of on-going pain which can result in further surgery to resurface the patella. NICE recommends always resurfacing the patella rather than never doing so. NICE did not find sufficient evidence on selective resurfacing (intraoperative decision based on the state of the patellar surface and the patients' symptoms) to make a recommendation on that strategy, but did recommend specific research was conducted on this question. If effective, selective resurfacing could result in optimal individualised patient care. This study evaluates the clinical and cost-effectiveness of elective primary TKR with always patellar resurfacing compared to selective patellar resurfacing.
Chief Investigator: Ashley Blom
Principal Investigator: Sven Putnis
Planned End Date: 31/03/2026
Local Ref: 4999
MyKneePlan: Named contact care plan for patients undergoing total knee replacement: intervention development
Over 100,000 knee replacements are performed every year in the UK. Most people recover by three months after surgery, but one in five will have ongoing pain and be dissatisfied with the results of their surgery. Some patients will have operations cancelled at short notice for avoidable medical reasons, which can have negative impacts on satisfaction and well-being.
Many patients feel abandoned after their knee replacement operation. Some report a lack of continuity of care and having to tell their story repeatedly to different health professionals. In other medical conditions, patients have a named contact, such as a specialist nurse, who manages expectations, monitors risk factors and other health conditions, and provides care, support, and education. This approach may be useful for knee replacement patients from before to after surgery, and we plan to develop such a care plan.
This project aims to develop a personalised care plan for patients undergoing total knee replacement to improve long-term outcomes after surgery. The care plan will be delivered by a named, dedicated healthcare professional who will provide continuity of care, and help patients to receive the treatments, support and education they need before and after their knee replacement surgery.
Chief Investigator: Wendy Bertram
Principal Investigator: Nick Howells
Planned End Date: 31/12/2024
Local Ref: 5336
HIPPY: Hip Implant Prosthesis Programme for the Younger total hip replacement patient
Over 100,000 hip replacements are performed each year in the UK. Around 90% of patients report good pain relief and mobility after surgery, and most implants last 25 years or more.
Primary hip replacement involves replacing a damaged hip joint with an artificial implant that has two main parts. One part goes into the leg bone and ends in a ball which fits into a socket or cup attached to the pelvis, making a ball-and-socket joint. Implants can be fixed to bone with cement (cemented), without cement (uncemented), or partially cemented (hybrid). Cost ranges from £500 for some cemented to £2,000 for some uncemented implants.
When an implant fails, for example due to loosening or wear, it has to be re-done. Revision is a major operation, typically costing the NHS over £10,000. Cemented hip implants are safe, inexpensive, have a long track-record, and offer the best value-for-money for men aged over 75 and women aged over 65 years. There is no high-quality evidence to suggest more expensive uncemented or hybrid implants are any better than cemented implants for younger patients. Yet three quarters of NHS patients aged under 70 years receive uncemented or hybrid implants.
This Programme of research aims to find out which hip implants are best for patients under 70 years of age.
Chief Investigator: Elsa Marques
Principal Investigator: Mike Whitehouse
Planned End Date: 01/07/2031
Local Ref: 5258, 5259
Elective Orthopaedics Studies:
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.
Principal Investigator: Mr Tony Ward
Planned End Date: 30/09/2027
Local Ref: 3275
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.
Principal Investigator: Mr Mark Crowther
Planned End Date: 01/10/2029
Local Ref: 3650
GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow-Up Study
This is a commercial study involving patients who need shoulder replacement surgery. It involves reviewing progress of patient with Global Icon 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 only be used anatomically.
Principal Investigator: Mr Iain Packham
Planned End Date: 01/01/2030
Local Ref: 4005
UK Multi-centre, observational, prospective, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System
A commercial study involving review of patients treated with an INFINITY Total Ankle Replacement. The study is collecting clinical and patient reported outcomes up to 10 years following surgery.
Principal Investigator: Mr Steve Hepple
Planned End Date: 31/12/2029
Local Ref: 4168
This study aims to compare two different plates currently used in knee realignment surgery (high tibial osteotomy). The purpose of the metal plates is to maintain the correct realignment achieved at surgery whilst the bone heals. The two plates, TomoFix and ActivMotion are both used in current practice and comply safety regulations.
Once the knee correction has healed (approx. 12 months) the plate can be left in. Some patients may however experience discomfort that related to the plate and benefit from plate removal , about a year after their initial operation. The ActivMotion plate design is a smaller than the Tomofix and it is therefore potentially less likely to cause discomfort . It is anticipated that second operations for plate removal will be less frequent than for the Tomofix plate.
In this study we would like to compare the number of plates that need removal following surgery, assess pain levels in patients in the first two years following surgery and compare the amount of pain relief used in the immediate post-operative recovery period.
Participants will be asked to complete a questionnaire before they have their operation and twelve months after the operation to assess their pain and function. This information will be used to compare the outcome of the plates.
Principal Investigator: Mr James Murray
Planned End Date: 31/03/2024
Local Ref: 3810
This study is a prospective, post-market, global, multi-center, non-controlled, observational clinical evaluation of the commercially available Persona® Partial knee implant. The primary objective of the study is to obtain survivorship data and assess clinical performance (outcomes) using outcome measurement tools (e.g. patient questionnaires), radiographic assessments and adverse event data.
In total, there will be 30 global sites in the US and Europe. In the UK, the multi-centre study is being conducted at four sites in England with a maximum of 40 patients at each centre. Male and female individuals aged 18 years and over, with a confirmed diagnosis of osteoarthritis and who qualify for unicompartmental (partial) knee surgery will be potentially eligible to take part. Each Investigator will offer study participation to each consecutive eligible patient who satisfies the Inclusion/Exclusion criteria for partial knee arthroplasty using the commercially available Partial Persona Knee.
Following completion of the informed consent process, participants will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Patients will then be asked to attend post-operative follow-up clinic visits at 3 months, 1 year, 2 year, 5 year and 10 year. At these follow-up visits, clinical and radiographic evaluations will be conducted.
Principal Investigator: Mr Andrew Porteous
Planned End Date: 31/12/2028
Local Ref: 3905
Hip Replacement Failure & Bone Density
Hip replacements are a very common operation for people with painful arthritis. However, sometimes these hip replacements need to be done again because of pain and loosening. We think that similar things may lead to loss of bone density (thinning of the bones) and loosening of joint replacements. Because of this there is concern that loss of bone density may increase the need for further surgery to correct the loose joint replacement.
The study aims to see if there are differences in bone density and other factors that may explain why some people need their hip replacements done again (revised) and some do not.
Principal Investigator: Dr Emma Clark
Planned end date: 31/12/2025
Local Ref: 2503
RAPSODI: Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI): a multi-centre, pragmatic, parallel group, superiority randomised controlled trial.
Patient aged 60 years or over with painful OA of the shoulder and an intact rotator cuff presenting to secondary care and through shared making, having completed non-surgical treatments, proceeding to shoulder replacement. In shoulder replacement surgery, doctors remove the damaged parts of the shoulder and replace them with plastic or metal parts.
The RAPSODI-UK study compares two types of shoulder replacement: the Total shoulder replacement, and the Reverse Shoulder replacement. These are the two types of shoulder replacement that NHS doctors use most often for patients with arthritis who need a shoulder replacement.
They both help to reduce pain, and maintain or improve movement. However, doctors genuinely don’t know yet which one works best.
Principal Investigator: Mr Mark Crowther
Planned end date: 30/08/2024
Local Ref: 5267
IMPACT: Evaluation of safety and efficacy of a resorbable collagan IMplant in treatment of High Grade PArtical thiCkness Tear; A prosepctive, mulitcentre, randomized, control trial
Patients who are 18 years and over, with a partial rotator cuff injury who’s symptoms persist following 3-6 months of conservative treatment are eligible for this study.
Impact study compares two types of surgery:
The rotator cuff is a group of muscles and their tendons that act to stabilize (hold in place) the shoulder. Torn rotator cuff tendons are common injuries that result in shoulder weakness and pain. These injuries can be treated with medications, injections, and physical therapy. However, when symptoms continue despite these treatments, surgery is often recommended to repair the injured tendon. An alternative to standard surgical procedures for repairing torn rotator cuff tendons involves applying a protective layer of collagen over the injured tendons to aid in healing and stop disease progression. Collagen is the most commonly found protein in the body and is present in the skin, bones, tendons and ligaments. The collagen is extracted from bovine Achilles tendons (from cows).
The purpose of this study is to find out if the marketed REGENETEN™ Bioinductive Implant is better than standard repair techniques for surgically treating partial-thickness rotator cuff tears. Smith+Nephew is the company paying for the study and REGENETEN is one of their products.
Principal investigator: Iain Packham
Start date: March 2023
End date: June 2026
Local ref: 5311
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