Orthopaedics Completed Research

Total knee replacement surgery helps to reduce pain and decreased mobility related to osteoarthritis. Around 100,000 of these operations are done in the NHS each year, but one-in-five people (20,000 patients) who have this operation have ongoing pain afterwards.

We looked into ways to improve the care for people with ongoing pain after knee replacement and developed the STAR care pathway to guide this care. In the care pathway, a trained healthcare professional assesses a person’s knee joint and recommends further healthcare that is specific to that person’s difficulties and pain. People who received the care pathway also received telephone follow-up for one year. A trial was run to find out if the STAR care pathway was helpful. It was found that people who received the care pathway had less pain, fewer hospital admissions, shorter hospital stays and fewer unpaid days off work over the next year.

This programme of work aimed to benefit patients with long-term pain after total knee replacement by implementing new research findings into the NHS and by understanding long-term outcomes.

Project details

Chief Investigator: Rachael Gooberman-Hill

Principal Investigator: Nick Howells

End Date: 31/01/2023

Local Ref (R&D no): 4994

Total knee replacement is the third most common non-emergency procedure in the UK. It involves replacing a damaged or painful joint with an artificial joint in order to reduce pain and improve function. Results after a total knee replacement are good, however up to 20% of patients will continue to experience dissatisfaction with their surgical outcome and mild to severe long-term pain after surgery. In order address this issue, new approaches are needed to improve surgical outcomes and reduce pain in this patient group.

The aim of this study is the preliminary development of a new non-pharmacological approach to improve sleep quality and duration in patients undergoing total knee replacement. Sleep is bidirectionally linked to pain and improving sleep in this population has the potential to significantly benefit a wide range of patients and improve long-term outcomes.

The first step in this process is to fully understand the problem and its causes. To date, very little is known about the exact nature of sleep behaviour and problems in the total knee replacement population. This study will use a mixed methods approach to explore individual sleep experiences and patterns through the use of qualitative focus groups, questionnaires, and wearable sleep monitors. This data will enable us to identify the nature of sleep problems within this population, which of these problems have the greatest potential for change, and how to can bring about this change.

Project Details
Principal Investigator: Katie Whale
Study Completion: 30/06/2020
Local Ref: 4473

Our proposed study will run a trial of 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.

Project Details
Principal Investigator: Dr Nick Howells
Study Completion: 30/06/2020
Local Ref: 3759

Osteoarthritis is a common problem that causes pain and disability. Many people with severe pain related to osteoarthritis have an operation called a total knee replacement. Total knee replacement involves replacing the worn and painful joint surfaces with a metal and plastic implant. It is a major operation and most people experience some pain in the first three months after surgery. One in five patients however report ongoing pain after this initial three-month recovery period. We call this ‘long-term’ or ‘chronic’ pain. In the UK in 2017 there were nearly 100,000 primary total knee replacements performed, so this means that around 20,000 people have long-term pain afterwards. Long-term pain can negatively affect people’s activity and physical and mental wellbeing. We know that many people do not receive or seek care for long-term pain after surgery. Improving care and support for people with long-term pain after knee replacement will benefit patients, the NHS and society.

We are running a trial to investigate whether a new care pathway provides benefits to patients with long-term pain after total knee replacement. The STAR (Support and Treatment After Replacement) care pathway involves a clinic appointment at 3 months after knee replacement with a healthcare professional to better understand the possible causes of pain after knee replacement. People are then referred on to see other relevant health professionals for treatment as needed, such as physiotherapists, orthopaedic surgeons, GPs, and pain specialists. Patients are then followed-up by the healthcare professional with telephone calls over the next year. The findings from this trial 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. If the care pathway does benefit patients, we would then like to see it routinely offered to all NHS patients with long-term pain after knee replacement. The aim of this project is to understand whether the clinicians who have used the pathway with patients during the trial have found it to be acceptable or not, and what has helped or hindered them when using it in practice. In this project, we will talk to healthcare professionals from 8 different hospitals who have delivered the STAR care pathway as part of the trial. We will ask them what they think about the care pathway, whether it was acceptable or not, and how its delivery could be improved, so that it could become part of normal care.

Project Details
Principal Investigator: Andrew Moore
Study Completion: 31/01/2020
Local Ref: 4538

Published in the Lancet Medical Journal on 27 January 2022, the study found the STAR care pathway reduces pain severity, the amount pain interferes with people’s lives and is cost-effective.  The new treatment could potentially save the NHS up to £14 million per year through reduced inpatient admissions.

The study found patients who received the STAR care pathway had:

• Less pain severity and impact on daily life at both six and 12 months after treatment (nine and 15 months after surgery)
• Half the number of hospital re-admissions
• Reduced length of hospital stay for any inpatient admissions three months after surgery
• Less unpaid time off work

Brenig, a participant on the STAR Trial, explained: “As part of the STAR trial, you have tailored physiotherapy appointments.  At my three-month review with a STAR physiotherapist, I was having a problem not being able to straighten my leg out.  She gave me some simple exercises, which worked and straightened the leg out.  Occasionally I have problems at the back of the knee, then I do the exercises and it goes back to normal. So that was a very positive side of what we actually did.  

“I felt that being part of the STAR trial gave me access to a specialist physiotherapist. Her knowledge was far, far superior and specific to my issue.  Some mornings I get up and feel on top of the world and then the following day I have leg pain.  Eventually you get to accept it, but doing the exercises helps.”

A video explaining the STAR care pathway (Support and Treatment After joint Replacement) is available on YouTube, see: https://youtu.be/8DN5FzmzZe4

Lancet Paper

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.

Project Details
Principal Investigator: Ms Lindsay Smith
Study Completion: 28/02/2019
Local Ref: 3752

The study examined the most appropriate treatment for frozen shoulder. It compared 2 types of surgical intervention with a Physiotherapy programme alone. Patients were randomised to either the structured Physio programme, manipulation under anaesthetic with a steroid injection or manipulation under anaesthetic with surgical release of the tissues in the shoulder. Patients were assessed with a series of patient completed questionnaires up to 12 months from their surgery.

Project Details
Principal Investigator: Mr Mark Crowther
Study Completion: 30/06/2019
Local Ref: 3591

This study examined whether it was feasible to conduct a definitive study to examine whether it most appropriate to treat spinal stenosis (narrowing of the spinal canal) with a decompression alone or with decompression and fusion. Patients were randomly assigned to receive one of the two types of surgery and were followed-up for 6 months post-surgery.

Project Details
Principal Investigator: Mr Ian Harding
Study Completion: 30/09/2020
Local Ref: 4506

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.

Project Details
Principal Investigator: Mr Steve Hepple
Study Completion: 31/05/2020
Local Ref: 3521

This feasibility study examined whether it was possible to conduct a definitive study to determine the most appropriate treatment, surgical or non-surgical, for a type of pelvic fracture sustained from high energy accidents such as road traffic collisions or falls from horses etc. Patients were randomly assigned to surgical or non-surgical treatment and were reviewed up to 12 months following their injury. The study demonstrated that it is possible to conduct a definitive study to identify the most appropriate management of these injuries.

Project Details
Principal Investigator: Mr Mez Acharya
Study Completion: 31/12/2020
Local Ref: 4115

This study examined the surgical treatment of trochanteric hip fractures. Patients in the study were randomised to fixation either with a sliding hip screw or the X-bolt system. Patients were follow-up for 12 months post-surgery.

Project Details
Principal Investigator: Mr Mike Kelly
Study Completion: 30/04/2019
Local Ref: 3694

This study examined the use of negative pressure wound dressings following surgery for hip fractures in the prevention of wound infections. Patients undergoing surgery for a hip fracture were randomly allocated to either have a negative pressure wound dressing or a standard dressing applied following their surgery. Patients were monitored up to 4 months following their surgery.

Project Details
Principal Investigator: Mr Andrew Riddick
Study Completion: 31/07/2018
Local Ref: 4129

This study examined 2 types of surgery for proximal humeral (shoulder) fractures. Patients in the study were randomly allocated to receive either a complete shoulder replacement or a partial replacement. Patients were monitored with questionnaires and physical assessments up to 2 years post-surgery.

Project Details
Principal Investigator: Mr Mark Crowther
Study Completion: 25/07/2019
Local Ref: 2943

This study examined the use of negative pressure wound dressings following surgery for lower limb injuries in reducing the risk of infection. Patients were randomly allocated to either receive a negative pressure wound dressing or standard dressing following surgery. Patients were monitored for 5 years post-surgery.

Project Details
Principal Investigator: Mr Andrew Riddick
Study Completion: 01/03/2019
Local Ref: 3706

The study involved the development and testing of a new patient questionnaire to monitor patients’ recovery following major lower limb injuries.

Project Details
Principal Investigator: Mr Mike Kelly
Study Completion: 31/07/2017
Local Ref: 3519

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.

Project Details
Principal Investigator: Mr Mike Kelly
Study Completion: 01/12/2020
Local Ref: 4068

Some broken ankles can be treated without an operation, in either a plaster cast or boot, but others need an operation to fix the bones into their normal position whilst they heal. There are a range of different ankle operations available, including using a metal rod, or ‘nail’, passed through the bottom of the heel up into the shin bone to hold the broken bone ends together whilst they heal – known as a ‘tibiotalocalcaneal’ or ‘TTC’ nail. Although these nails are currently in use across NHS hospitals, there is differing opinion on their outcome.

This study will record the outcomes of patients treated with a TTC nail at North Bristol NHS Trust.

Project Details
Principal Investigator: Mr Andrew Riddick
Study Completion: 17/06/2021
Local Ref: 4352

This study looked at comparing two different treatments for patients over the age of 60 who had broken their ankle. One treatment involved an operation to set the ankle bones by inserting plates and screws to hold the bones in the correct position whilst they heal (Open Reduction Internal Fixation). The other treatment involved the patient wearing a “close contact cast” that fits the leg very closely and holds the ankle bones securely. The study wanted to know which of these two treatments was best.

Project Details
Principal Investigator: Mr Steve Hepple
Study Completion: 20/09/2015
Local Ref: 2272

This study looked at comparing two different treatments for patients who had broken their wrist. Some broken wrists can be treated in a plaster cast. However those that can’t will need to be manipulated back into their original position and then held in that position until they have healed. The operation to hold the bone in its best position is called a ‘fixation’. The two forms of fixation that were compared in this study were “K-wire fixation” and “plate and screw fixation”. The study wanted to know which of these two treatments was best.

Project Details
Principal Investigator: Mr Tim Chesser
Study Completion: 25/11/2013
Local Ref: 2453

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.

Project Details
Principal Investigator: Mr Mark Crowther
Study Completion: 30/04/2013
Local Ref: 2123

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.

Project Details
Principal Investigator: Mr Iain Packham
Study Completion: 30/04/2015
Local Ref: 2456

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.

Project Details
Principal Investigator: Mr Steve Hepple
Study Completion: 01/12/2017
Local Ref: 3463

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.

Project Details
Principal Investigator: Mr James Murray
Study Completion: 28/02/2017
Local Ref: 3004

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.

Project Details
Principal Investigator: Mr Tim Chesser
Study Completion: 31/12/2016
Local Ref: 2706

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.

Principal Investigator: Mr Mike Kelly
Study Completed: 31/12/2017
Local Ref: 3221

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).

Project Details
Principal Investigator: Mr Umraz Khan
Study Completion: 31/01/2017
Local Ref: 2865

The initial DRAFFT study showed no benefit from surgical fixation of distal radius fractures (broken wrists) with plate and screws when compared to fixation with wires. This study compared the treatment of patients with broken wrists with either surgical fixation with wires to non-operative management in just a plaster cast. The study aimed to show whether surgical fixation with wires provided any benefit over just treating these injuries with a plaster cast.

Project Details
Principal Investigator: Mr Tim Chesser
Study Completion: 01/11/2019
Local Ref: 3891

Pubic Rami, or LC1, fractures are common in the elderly. Generally, they are treated without surgery. However operative fixation of the fracture may reduce patients’ level of pain and allow them to mobilise easier following their injury. Patients in the study are randomised to either non-operative management or surgical fixation of their fracture. Patients will be monitored up to 6 months following surgery with the completion of questionnaires and physical assessments.

Project Details
Principal Investigator: Mr Mez Acharya
Study Completion: 13/08/2021
Local Ref: 4500

This study began in 2012 and aims to record important quality of life outcomes in patients over the age of 60 who have broken their hip and needed an operation.  This is done by asking the patients to answer baseline questions about their quality of life before they broke their hip and then asking these questions again at four months after their injury as well as taking data from their medical notes about their treatment pathway. It is a multi-centre study involving 12 hospitals aiming to evaluate the service and make service improvements, with more than 10,000 patients already recruited to the study and counting.

In addition, the clinical effectiveness of experimental interventions will be explored with embedded trials within the WHITE study. Examples of this include WHITE four which compared sliding hip screw vs x-bolt fixation for trochanteric hip fractures and WHISH which compared infection rates of incision sites for patients receiving standard wound management vs negative pressure wound therapy.

Project Details
Principal Investigator: Mr Mehool Acharya
Planned End Date: 01/12/2022
Local Ref: 3374

This is a study in conjunction with the World Hip Trauma Evaluation investigating the difference in infection rates in patients after hip hemiarthroplasty when a dual antibiotic is used in the cement compared with the current standard care which is a low dose single antibiotic.

Project Details
Principal Investigator: Mr Tim Chesser
Planned End Date: 01/12/2021
Local Ref: 4278

This study is investigating the use of Cell Salvage during surgery for hip fractures. Cell Salvage involves collecting the patient’s own blood that is lost during surgery, processing it and transfusing it back to the patient during their surgery. This may potentially reduce the need for autologous blood transfusion post-operatively. Patients are randomly allocated to either receive Cell Salvage or standard care and outcomes are monitored up to 12 months post surgery.

Project Details
Principal Investigator: Prof Mike Whitehouse
Planned End Date: 31/01/2023
Local Ref: 4728

Within the shoulder there are a group of small muscles and tendons called the rotator cuff. Tears of the rotator cuff tendons are very common. They can be very painful, and it can be difficult to move the shoulder normally. When a tear cannot be repaired, one common treatment is a keyhole operation to clear space around the tendons and remove the painful tissue. This is called an arthroscopic debridement. This study compares treatment of Rotator Cuff tears with arthroscopic debridement only, or arthroscopic debridement and insertion of Inspace Balloon which is made of biodegradable synthetic material and is thought to cushion inside the joint.

Project Details
Principal Investigator: Mr Iain Packham
Planned End Date: 01/01/2022
Local Ref: 4249