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Orthopaedics Current 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:

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.

Project Details
Principal Investigator: Nick Howells
Planned End Date: 31/12/2021
Local Ref: 4781

Support and treatment after joint replacement (STAR): Long-term follow up of a care pathway for patients with long-term pain after knee replacement

The STAR Trial was conducted in eight hospitals in the UK. The trial tested whether the new STAR care pathway provided benefit to a group of people with troublesome pain three months after knee replacement compared with a group receiving usual care.

We invited over 5000 people to tell us how they were doing after their operation. 3058 responded, 907 reported ongoing pain 10 weeks after surgery, and almost 400 reported ongoing pain at three months. 363 took part in the trial, with 313 completing all of the questionnaires.

Participants told us about their pain and how much it interfered in their lives at the start of the trial and again six and twelve months later. We also collected information about their hospital stays and appointments during the trial.

We found that people who received the STAR care pathway had better outcomes. They had less pain, better recovery from their surgery and fewer hospital stays compared to those having only usual care. We also found the care pathway provides good value for money for the NHS. Participants were sent a summary of the results in December 2020.

We now want to understand the longer-term experiences of people with pain after knee replacement and the effect of the STAR care pathway compared with usual care. This will involve contacting patients about four years after they first started in the trial and asking them to complete one questionnaire to tell us how they are getting on. We will also collect information from their hospital about any stays or appointments in the past few years.

This information will help us understand if people who had the STAR care pathway continue to have better outcomes and if this provides good value for money for the NHS in the longer term.

Project Details
Principal Investigator: Nick Howells
Planned End Date: 06/11/2021
Local Ref: 4944

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.

Project Details
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.

Project Details
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.

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

Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

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

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

METRO

The meniscus is a cartilage-based structure within the knee which is susceptible to damage or tears following high energy injury or low energy injury in a knee with signs of arthritis. Treatment for meniscal tears can include either physiotherapy or surgery where the damaged meniscus is removed. Recent high-quality studies have shown physiotherapy is as effective as surgery in patients over 55. A potential reason for this is in patients over 55 there may be coexisting arthritis within the knee which is the source of symptoms rather than the meniscal tear. There is a clear need for high quality trial in younger patients aged under 55. Before a trial is commenced it is imperative to understand the trial population better.

The purpose of this study is to identify the symptoms patient present with, the presence of signs of arthritis on imaging and whether these features influence treatment outcome. We also aim to explore patient experiences of living with a meniscal tear.

We aim to perform a multicentre study where will follow up patients under 55 with an isolated meniscal tear to identify the symptoms and imaging findings patients present with. We will then follow up these patients over one year to identify if these symptoms or imaging signs affect treatment success. In addition, we will identify the current treatment pathways for patients with a meniscal tear.

20 participants from the main study will be invited to take part in interviews where we aim to identify patient experiences on living with a meniscal tear and views on a future large-scale trial.

This study will provide clinicians with a greater understanding of meniscal tears in young patients and help aid treatment decisions.

Project Details
Principal Investigator: Mr Andrew Metcalfe
Planned End Date: 30/05/2022
Local Ref: 4647

ACL SNNAP

The primary objective of this multicentre Randomised Controlled Trial is to determine in patients with non-acute (greater than 4 months since injury) Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [physiotherapy rehabilitation with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management [reconstruction].

Undergoing structured rehabilitation first may prevent the need for surgery. This was observed in a Scandinavian study, where ACL injury treatment is given more immediately following injury (when injury is acute) unlike in the UK where treatment generally commences after a few months following injury (injury is non-acute). If it is found that rehabilitation treatment of non-acute ACL injuries is successful, it will mean that patients may not need to undergo surgery. The treatments provided in this study will be the standard operative or non-operative treatment currently provided in the UK.

Having surgery includes NHS waiting times, potential operative and anaesthetic risks and is a more expensive treatment option. Both treatment groups will be monitored to make sure the treatment allocated to them is appropriate. However, if rehabilitation is unsuccessful, patients with continued instability may still require surgery. Furthermore, the participant will be required to complete a baseline questionnaire and three follow-up questionnaires at six, twelve and eighteen months.

Project Details
Principal Investigator: Mr James Murray
Planned End Date: 12/02/2022
Local Ref: 3896

ReMatch

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

PERSONA

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

ALLIKAT

Knee replacement surgery is a common treatment for osteoarthritis of the knee. There are different types of knee replacement systems, or ‘implants’, that can be used in the surgery. The Knee replacement surgery is a common treatment for osteoarthritis of the knee. There are different types of knee replacement systems, or ‘implants’, that can be used in the surgery. The research looking at modifications and design changes to these implants is limited. Research is needed to consider the changing characteristics of the patients who require knee surgery. Currently there is an increase in demand for knee replacement in a younger and more active population, who desire less limitation on their activities following knee replacement surgery.

Current knee replacement designs sacrifice one of the main ligaments in the knee, called the Anterior Cruciate Ligament (ACL). By preserving natural knee structures, such as the ACL, it is thought that the knee will retain more normal function following surgery.

The Vanguard CR is a commonly used knee replacement, and it sacrifices the ACL. Zimmer Biomet have developed a new knee replacement implant called the Vanguard XP which keeps all the main knee ligaments intact. This new design may benefit the younger, more active population.

ALLIKAT is a research study which will evaluate the early outcomes of the Vanguard XP compared to the Vanguard CR. Patients will be followed up for 3 years, with information about complications both during and following the surgery, as well as patient reported outcomes. 200 patients will be randomised to receive either the Vanguard CR or the Vanguard XP, and they will not know which one they receive. There will also be a smaller group of 60 participants who will only receive the Vanguard XP. The data from this cohort group will contribute to safety and efficacy evaluation of the new implant. 260 patients will be recruited in total from 5-6 NHS sites around the UK.

Non-identifiable data collected from the cohort group combined with the data from those randomised to the Vanguard XP will contribute to the Beyond Compliance Program which has been set up in the interest of patients, to support the safe and stepwise introduction of new or modified medical implants such as joint replacements.

Project Details
Principal Investigator: Mr Andrew Porteous
Planned End Date: 30/06/2021
Local Ref: 3770

Trauma Orthopaedics Studies:

World Hip Trauma Evaluation

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

WHITE 8: A Randomised Controlled Trial of low dose single antibiotic loaded cement versus high dose dual antibiotic loaded cement in patients receiving a hip hemiarthroplasty after fracture

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

WHITE 9: A multi centre randomised controlled trial comparing intra operative cell salvage with standard care in the treatment of hip fractures.

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

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

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’).

Project Details
Principal Investigator: Mr Mark Crowther
Planned End Date: 01/05/2023
Local Ref: 4202

The Fractured Ankle Management Evaluation (FAME)

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

SOFFT: Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial (Simple Olecranon Fracture Fixation Trial – SOFFT)

Displaced fractures of the Olecranon (elbow) are usually managed surgically using metal wires or plate & screws to repair the broken bone. In some patients this can cause long term discomfort and require further surgery to remove the metalwork. Fixation of the bone fragments using a strong suture may reduce the incidence of this discomfort and the need for further surgery. Patients in this study are randomly allocated to undergo fixation with either the suture or wire fixation. Patients are monitored up to 2 years post-surgery.

Project Details
Principal Investigator: Mr Iain Packham
Planned End Date: 31/03/2024
Local Ref: 4862

The Humeral Shaft Fracture Trial (HUSH)

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: 01/10/2023
Local Ref: 4852

Acute Rehabilitation following Traumatic anterior shoulder dislocation: Multi Centre Randomised Controlled Trial (ARTISAN)

Shoulder dislocations occur when the upper end of the arm bone is forced out of its joint socket. Most people do not need an operation, but there is no research available to tell us what to do next.

Currently in the UK, some hospitals offer a single session of physiotherapy and some offer a course of physiotherapy. The UK guidelines currently say a course of physiotherapy ‘may be helpful’; whilst other national guidelines say a single session alone is needed.

The purpose of this research study is to find out if the ARTISAN Programme with additional sessions is any better than the ARTISAN Programme alone for patients who have dislocated their shoulder. 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 Investigators: Mr Iain Packham & Mrs Rhian Witham
Planned End Date: 01/07/2022
Local Ref: 4330

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Telephone: 0117 4149330
Email: research@nbt.nhs.uk