Nurse tending to a patient

Orthopaedics Completed Research

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.

An integral part of South West Regional Trauma Centre 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.

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.

Academic Orthopaedics Studies:

Exploring sleep behaviour and problems in patients undergoing total knee replacement surgery

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

The STAR Trial: Evaluation of a care pathway for patients with long-term pain after knee replacement

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

Evaluating the Implementation of the STAR Care Pathway – An interview study

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

Elective Orthopaedics Studies:

WHISTL:ER 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.

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

UKFROST – United Kingdom Frozen Shoulder Trial

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

SPINOUT-F – The Spinal Fusion Indications and Outcomes Randomised Trial – a Feasibility study

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

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.

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

Trauma Orthopaedics Studies:

TULIP – A Randomised Controlled Trial of Surgical versus Non-Surgical Treatment of Lateral Compression Injuries of the Pelvis with Complete Sacral Fractures (LC1) in the Non-fragility Fracture Patient - A Feasibility Study.

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

WHITE4 – A randomised controlled trial of the sliding hip screw versus X -Bolt dynamic plating system for the fixation of trochanteric fractures of the hip

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

WHITE7 (WHISH) – Wound Healing in Surgery for Hip fractures

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

SHeRPA – Shoulder Hemiarthroplasty or Reverse Polarity Athroplasty for Trauma Study

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

WHIST – Wound Healing in Surgery for Trauma

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

WaLLTR – Measuring Recovery in Open Lower Limb Fractures: The Development of a Novel Patient Centred Recovery Score for Lower Limb Trauma

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

Ankle Injury Rehabilitation

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

Outcomes of Ankle Fractures Treated with Primary Retrograde Tibiotalocalcaneal (TTC) Intramedullary Nail in a Major Trauma Centre

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

AIM – Ankle Injury Management

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

DRAFFT – Distal Radius Acute Fracture Fixation Trial

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

PROFHER – 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.

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

London Clavicle

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

PATH-2: 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.

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

FixDT – 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.

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

INSITE – 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.

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

Ulnar Fracture Study

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

WOLLF – 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).

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

Distal Radius Acute Fracture Fixation Trial 2

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

L1FE – Lateral compression type-1 fracture fixation in the elderly, a randomised controlled trial

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

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Research & Innovation
North Bristol NHS Trust
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Southmead Hospital
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Telephone: 0117 4149330
Email: research@nbt.nhs.uk