Orthopaedics Current Research

Peri-Op Iron and Erythropoietin (EPO) Intervention Study 

After surgery it is common for a component of blood known as haemoglobin to drop which can lead to anaemia and poor healing, leading to a longer hospital stay. Therefore, with this study we aim to find out if additional medication to support the bodies’ production of iron will help to reduce occurrence of anaemia. 

Project Details:

Principle Investigator: Katherine Walsh 

Planned end date: 31/07/2025

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.

Project Details:

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 16 years and over 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.

Project Details:

PI: Mr Damian Clark

Start Date: Dec 2023

End Date: Aug 2025

Local Ref: 5440

This study compares surgery to sling immobilisation in the management of adults with a displaced fracture of the distal clavicle (Collarbone) in patients over the age of 18 years old with 21 days of injury. 

When the outer end of the collarbone has broken, parts of the bone may separate and not line up. This can rupture the ligaments connecting the collarbone to the shoulder blade. Doctors commonly treat this type of injury that have had with: A sling, to help support the shoulder while the bone heals naturally; or surgery that uses metal work to try the separated bone while they knit together naturally.  Both treatments work but we do not know which one works the best. The aim of this study is to find this out. 

Project Details:

PI: Iain Packham 

Start Date: December 2023

End Date: 30 June 2025

Local Ref: 5405

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.

Project Details:

PI: Kirsty Derrick

Start Date: August 2024

End Date: August 2025

Local Ref: 5285

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.

Project Details:

Principal investigators: Alasdair Bott and Fran Verey

Start date: 03/2023

End date: 12/2024

Local ref: 5350

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.

Project Details:

Principal Investigator: Andy Riddick

Planned End Date: July 2025

Local ref: 5215

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.

Project Details:

Principal Investigator: Dr Paddy Morgan

Planned end date: June 2025

Local Ref: 5120

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.

Project Details:

Principal Investigator: Edd Carlton

Planned end date: May 2025

Local Ref: 4927

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.

Project Details:
Principal Investigator: Mr Alasdair Bott
Planned End Date: Feb 2025
Local Ref: 4852

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.

Project Details:
Principal Investigator: Mr Mike Kelly
Planned End Date: 01/01/2027
Local Ref: 4607

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’).

Project Details:
Principal Investigator: Mr Mark Crowther
Planned End Date: June 2025
Local Ref: 4202

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.

Project Details:

Principal Investigator: Mr Tim Chesser
Planned End Date: 31/01/2029
Local Ref: 4695

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.

Project Details:
Principal Investigator: Nick Howells
Planned End Date: 31/08/2022
Local Ref: 4781

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.

Project Details:

Chief Investigator: Rachael Gooberman-Hill

Principal Investigator: Nick Howells

Planned End Date: 31/08/2023

Local Ref: 5069

Infection and Orthopaedic Management, 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.

Project Details:

Chief Investigator: Andrew Moore

Planned End Date: 31/10/2023

Local Ref: 5069

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.

Project Details:

Chief Investigator: Vikki Wylde

Principal Investigator: Mike Whitehouse

Planned End Date: 31/12/2023

Local Ref: 4999

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.

Project Details:

Chief Investigator: Ashley Blom

Principal Investigator: Sven Putnis

Planned End Date: 31/03/2026

Local Ref: 4999

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.

Project Details:

Chief Investigator: Wendy Bertram

Principal Investigator: Nick Howells

Planned End Date: 31/12/2024

Local Ref: 5336

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.

Project Details:

Chief Investigator: Elsa Marques

Principal Investigator: Mike Whitehouse

Planned End Date: 01/07/2031

Local Ref: 5258, 5259

This study aims to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement or arthroplasty in patients with severe osteoarthritis of the ankle.

Project Details:
Principal Investigator: Steven Hepple

Start Date: 02/09/24
Planned End Date: 31/05/2025
Local Ref: 5570

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.

Project Details:
Principal Investigator: William Poole
Planned End Date: 30/09/2027
Local Ref: 3275

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.

Project Details:
Principal Investigator: Mr Mark Crowther
Planned End Date: 01/10/2029
Local Ref: 3650

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.

Project Details:
Principal Investigator: Mr Iain Packham
Planned End Date: 01/01/2030
Local Ref: 4005

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.

Project Details:

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.

Project Details:
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.

Project Details:

Principal Investigator: Mr Andrew Porteous
Planned End Date: 31/12/2028
Local Ref: 3905

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.

Project Details:

Principal Investigator: Dr Emma Clark
Planned end date: 31/12/2025
Local Ref: 2503

 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. 

 Project Details:

Principal Investigator: Mr Mark Crowther  

Planned end date: 30/08/2024 

Local Ref: 5267 

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.

Project Details:

Principal investigator: Iain Packham

Start date: March 2023

End date: June 2026

Local ref: 5311