Trauma & Orthopaedics Current Research Projects

The team are managing a number of world-wide research studies that are looking to improve patient outcomes.

ARTISAN

Acute Rehabilitation Following Traumatic Anterior Shoulder Dislocation

Principal Investigator: Mr Ian PackhamArtizan trauma and orthopaedics

ARTISAN is a multi-centre randomized controlled trial comparing physiotherapy advice after first time traumatic non-operative shoulder dislocation with physiotherapy advice and a course of up to six sessions of physiotherapy.
The aim of ARTISAN is to establish if a single session of physiotherapy advice and a course of physiotherapy is superior to advice only following a first time traumatic shoulder dislocation.
The study will look at the patient’s progress through postal questionnaires and will also explore the implications on resources for patients and the NHS for 12 months after randomisation

Funded by National Institute for Health Research
Co-Ordinated by Warwick Clinical Trials Unit
Recruitment end date: 01 September 2020

(R&I No. 4330)

GLOBAL ICON

Stemless Shoulder System Post Market Clinical Follow up Study shoulder replacement surgery trial

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.
Recruitment end date: March 2019

(R&I number: 4005)

ProFHER-2

PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2 
trauma and orthopaedic research
Principal Investigator: Mr Mark Crowther
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’).

End Date: May 2023
Coordinated by: South Tees Hospitals NHS Foundation Trust
Funded by Health Technology Assessment Programme

(R&I number: 4202)

START:REACTS

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.
Funded by: National Institute for Health Research
Recruitment End Date: 30 Jun 2020

(R&I number: 4249)

TULIP Treating Pelvic Injuries

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 trauma and orthopaedic research tulip


Principal Investigator:  Mr Mehool Acharya
The pelvis can be broken in different ways but the most common is called ‘lateral compression type 1’ (LC1). Most of these injuries occur as a result of a major fall or impact from the side and may be treated with or without surgery. Surgery may reduce pain levels and enable people to walk more easily following their injury. However surgery is not without risks such as infection, nerve damage and the anaesthetic. Non-surgical management avoids these risks but may lead to prolonged periods of pain whilst the break heals and difficulty for patients with walking. This study involves asking participants to answer questionnaires at certain time-points during their recovery to provide a picture of their symptoms following their injury and how they are able to manage daily activities. 

This is a feasibility study to test out the recruitment process in the view of performing a definitive trial with the aim to conclude whether surgical or nonsurgical management of unstable LC1 fractures is most appropriate.
Coordinated by: Trauma Research Team at North Bristol NHS Trust
Funded by: National Institute for Health Research
End Date: 31/01/2020

(R&I number: 4115)

World Hip Trauma Evaluation

Principal Investigator:  Mr Mehool Acharyatrauma and orthopaedic research

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. 


End Date: July 2020
Coordinated by University of Oxford
Funded by National Institute for Health Research

(R&I number: 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 trauma and orthopaedic research

Principal Investigator: Mr Tim Chesser
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.
Coordinated by: University of Oxford
Funded by: National Institute for Health Research
End Date: 31/07/2021

(R&I number: 4278)

FAME

The Fractured Ankle Management Evaluation TrialFractured ankle evaluation trial

Principal Investigator: Mr Michael Kelly
This is a randomised controlled trial investigating two different treatments for patients aged between 18 and 60 years who have broken their ankle. To be eligible for this study the ankle must be broken in such a way that the bones in their ankle joint is no longer aligned and these are referred to as ‘unstable’ fractures. The aim of ankle fracture treatment is to re-align the ankle joint whilst the broken bones heal and to reduce the risks of problems such as stiffness. This can be achieved by an operation on the ankle where cuts are made around the ankle, to hold the bones correctly while they heal. An alternative non-surgical treatment involves applying a snug plaster cast called a close contact cast, carefully shaped to your ankle, to hold the bones correctly while they heal.
The purpose of this study is to investigate whether the non-surgical treatment option will provide patients with comparable ankle function and quality of life to those treated with surgery.
Coordinated by: University of Oxford
Funded: National Institute for Health Research

Expected Start Date: November 2019
(R&I No. 4607)

LIFE

Lateral compression type-1 fracture fixation in the elderlyLateral compression type-1 fracture fixation in the elderly

Principal Investigator: Mr Mehool Acharya
The pelvis can be broken in different ways but the most common is called ‘lateral compression type 1’ (LC1). This study is investigating the best way to treat patients aged 60 years or older who have sustained an LC-1 pelvic fracture arising from a low energy fall from standing height or less.
It is a randomised controlled trial comparing non-surgical versus surgical treatment (using an internal fixator which is a rod and screws placed under the skin). Surgery may reduce pain levels and enable people to walk more easily following their injury. However surgery is not without risks such as infection, nerve damage and the anaesthetic. Non-surgical management avoids these risks but may lead to prolonged periods of pain whilst the break heals and difficulty for patients with walking. This study involves asking participants to answer questionnaires at certain time-points during their recovery, as well as a walking assessment to provide a picture of their symptoms following their injury and how they are able to manage daily activities.
Sponsor: Bart’s Health NHS Trust
Coordinated by: York Trials Unit
Funded: The National Institute for Health Research Health Technology Assessment programme

Expected start date: October 2019

(R&I No. 4500)
 

SPINOUT-F

The Spinal Fusion Indication and Outcomes Randomised Trial – a Feasibility StudyThe Spinal Fusion Indication and Outcomes Randomised Trial
Principal Investigator – Mr Ian Harding

Spinal stenosis is the narrowing of the spinal canal causing compression of the spinal cord which leads to lower back and leg pain and claudication (cramping pain in legs induced by exercise).
This is a randomised controlled study looking at two different treatment options for spinal stenosis; spinal fusion in addition to decompression surgery compared to decompression surgery alone. Decompression surgery aims to relieve the pressure by on the nerves by removing bone and soft tissues. Instrumental fusion stabilises the spine using screws inserted into the vertebrae, connected with rods, to allow bony fusion over time. There is currently no robust evidence to determine which type of treatment is best for patients who have spinal stenosis.
The study will involve asking participants to answer questionnaires at certain time-points during their recovery to provide a picture of their symptoms following their injury and how they are able to manage daily activities, as well as an optional patient focus group.
Sponsor: University of Oxford
Funder:  National Institute of Health Research, Research for Patient Benefit
End date: 30/09/2020
(R&I No. 4506)

STAR (Support and treatment after joint replacement)

STAR (Support and treatment after joint replacement)

Many people with severe knee pain because of osteoarthritis have a total knee replacement, which involves replacing the painful knee joint with an artificial joint. Over 75,000 total knee replacements are performed annually by the NHS and as the population continues to age numbers are expected to rise.  People often find that they have pain in the first three months after surgery although most people get better.  About 1 in 5 patients have ongoing pain after 3 months, we call this long-term pain.

The STAR trial: Evaluation of a care pathway for patients with long-term pain after knee replacement. Our proposed study is investigating 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.

This project is funded  by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0613-20001). Due to be completed in 2020.

HIndFix

The Outcome of Ankle Fractures Treated with Tibiotalocalcaneal Nails

Principal Investigator: Mr Andrew Riddick

This study aims to assess the outcome of patients, with an unstable ankle fracture, who are treated with a tibiotalocalcaneal (‘hindfoot’) nail as their primary operation. Patients will be asked questions about their quality of life before they broke their ankle, and then at 6 weeks, 3 months and 6 months after surgery to monitor their progress. Information from their medical notes, and X-Rays, will also be used to provide information on outcome, including any complications.

Coordinated by: North Bristol NHS Trust
Funded: Stryker European Operations Limited

Start Date: January 2020     End Date: December 2021.
(R&I No. 4352)