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Research studies in progress in the Major Trauma Centre

The following studies are in progress in the Major Trauma Centre.

ARTISAN – Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN

Chief Investigator: Rebecca Kearney
Principal Investigator: Warren Sheehan and Steve Gwilym
Research Team: Brown J; Ellard DR; Parsons H; Karasouli E; Mason J; Torgerson D; Parson N; Kennedy M
Intervention: Single session physiotherapy advice for all, intervention a second physiotherapy session and guided internet based exercises
Assessments: Primary outcome, Oxford Shoulder Instability Score at 6 months (covers activities of living and pain)
Sample: 18 years and over with a first time anterior shoulder dislocation
Recruitment: Overall 478, Oxford 16
Study dates: June 2019 - September 2020

warwick.ac.uk/fac/sci/med/research/ctu/trials/artisan

FORCE – FOrearm Fracture Recovery in Children Evaluation

Chief Investigator: Dan Perry
Principal Investigator: Alex Novac
Research Team: Achten J; Spoors L; Dutton S; Applebe D; Costa M
Intervention: Soft bandage versus rigid immobilisation for wrist fractures (torus/buckle fractures of the distal radius with or without an injury to the ulna) in children
Assessments: Wong Baker FACE pain rating scale at 1 day, 1, 3 and 6 weeks, PROMIS (range of outcomes) and analgesic usage
Sample: Children 4-15 years old inclusive who have sustained a wrist fracture
Recruitment: In the Emergency Department, 348 in 4-7 age group and 348 in 8+ group
Study dates: February 2019 - June 2020

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/force

PROFHER 2 - PROximal Fracture of Humerus Evaluation by Randomisation - Trial no.2

Chief Investigator: Amar Rangan
Principal Investigator: Steve Gwilym
Research Team: DiMascio O; Kassam J; Keding A; Hewitt C; Thamanathan P
Intervention: Comparing effectiveness of surgical procedures (Reverse arthroplasty vs hemi arthroplasty) vs non-surgical treatment
Assessment: Physiotherapy until discharge, Oxford Shoulder Score (OSS measure of pain and function), PROMIS (range of outcomes), EQ5D-5L (Quality of life), health economics
Sample: 65+ within 3 weeks of injury, fractured humerus with 3-4 parts
Recruitment: Overall 381, Oxford 18
Study dates: August 2018 - June 2021

TuLIP - Trial of surgical versus non-surgical treatment of Lateral compression Injuries of the Pelvis - A feasibility study

Chief Investigator: Mez Acharya
Principal Investigator: David Noyes
Research Team: Carpenter C; Barnfield S; Halliday R; Greenwood R; Ingram J; Kandiyali R; Griffin X
Intervention: Surgical versus non-surgical treatment
Assessment: IOWA pelvic score (pain and activity), Oxford Hip Score (pain and activity), EQ-5D-5L (quality of life), ICECAP (well being), Brief pain inventory, Timed up and Go
Sample: Lateral compression injury (LC1), fracture with sacral fracture, 16+ years, high energy mechanism of injury
Recruitment: Overall 40 - 60, Oxford 4
Study dates: April 2018 - Jan 2020

SCIENCE: Surgery or Cast for Injuries of the EpicoNdyle in Children's Elbows

A multi-centre prospective randomised superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures (elbow) of the humerus (upper arm) in children

Chief Investigator: Dan Perry
Principal Investigator: Mark Deakin
Research Team: Louise Spoors (Trial manager); Matt Costa; Juul Achten; Melina Dritsaki; Susan Dutton; James Wright
Intervention: Cast/splint or operative treatment
Assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children Computer Adaptive Test, DASH Sports/Performing Arts Module, Wong Baker Faces Pain Score, and health-related quality of life using the EuroQoL EQ-5DY at 6 weeks, 3, 6, 12 months, thereafter yearly until they are 16 years old
Sample: 7-15 years with a medial epicondyle fracture (elbow) of the humerus (upper arm)
Recruitment: Overall 334, Oxford 4
Study Dates: 24/6/21 - 31/5/2021

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/science
science.digitrial.co.uk

HIPGEN - Allogeneic ex-vivo expanded placental Stromal cells PLX-PAD

HIPGEN is a European funded study, investigating the effect of injections of Stem cells (PLX-PLD) on patients who have sustained an Intracapsular neck of femur fracture (break at the top of the thigh bone). Previous studies indicate that individuals that receive this intervention may have an improvement in recovery of muscle function and related functional impairment following hip fracture surgery.
Chief Investigator: Reuven Chantre (Israel)
Principal Investigator: Jowan Penn-Barwell, Matt Costa
Research Team: Local team Kathryn Lewis, Maria Mestre, Tessa Sewdin, Sangeetha Prasath
Intervention: Intramuscular injection of stem cells for muscle injury following hip surgery
Assessment: The patients will receive standard rehabilitation and this will be monitored by the research team at day 5, week 6, 12, 26, 52 and 104. Patients will also receive a DEXA scan at these points (to assess bone strength). The primary end point is the change from day 5 to week 26 in the Short Physical Performance Battery (SPPB) score (walking speed, balance and speed of standing from sitting).
Sample: 240
Recruitment: Oxford 20
Study dates: October 2019 - March 2020

www.hipgen.eu

PTRON: Primary Tumour and Research Outcome Network

PTRON is a multicentre prospective case series for the management of the primary tumors of the spine. It aims to establish a network of spine oncology centres, in order to conduct prospective research with patients who have been diagnosed with a primary tumour of the spine. Data is collected through a variety of sources, from inpatient and outpatient visits, from medical notes, electronic patient records and from imaging.

Chief Investigator: Charles Fisher
Principal Investigator: Jeremy Reynolds
Research Team: Local team Maria Mestre; Kathryn Lewis; Tessa Sewdin
Intervention: No intervention, embedded studies to follow
Assessment: Patients with primary tumours of Spine age 13 years and over
Sample: Open
Recruitment: Initial aim is 100
Study dates: October 2017 - open ended

STIFF-F: Segmental Tibial fractures, reamed Intramedullary nailing versus circular Frame external Fixation - A Feasibility study

To assess the feasibility of a multicentre RCT comparing intramedullary nailing with circular frame external fixation.

Chief Investigator: Caroline Hing
Principal Investigator: Sandy Woods
Research Team: Jonathan Cook; Matt Costa; Liz Tutton; Toby Smith; Melina Dritsaki; Cushla Cooper; Molly Glaze
Intervention: Intramedullary nailing or circular frame external fixation
Assessment: Disability Rating Index, EQ-5D-5L, Pittsburgh Sleep Quality Index (PSQI), Tampa Scale for Kinesiophobia, health resource use questionnaire at 3, 6 months post injury.
Sample: Adults (16 years and over) with a segmental tibial fracture (open or closed) deemed suitable for either an intramedullary nail or an external fixation
Recruitment: Overall aim 50, Oxford 1
Study dates: Oxford Nov 2019 - Jan 2020

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/stiff-f

L1FE: Lateral compression type-1 fracture Fixation in the Elderly, a randomised controlled trial

To investigate the effectiveness, safety and cost-effectiveness of internal fixation with devices such as INFIX (a type of fixation device) compared to nonsurgical treatment.

Chief Investigator: Peter Bates (Barts Health NHS Trust)
Principal Investigator: David Noyes
Research Team: Mays Jawad; Mike Backhouse; Liz Cook; Joanne Laycook; Seleema Rex; Belen Corbacho
Intervention: Anterior internal surgical fixation device or non-surgical management
Assessment: Quality of life EQ-5D-5L, Patient Reported Outcome Measure Information System (PROMIS): Lower Extremity Function, PROMIS Scale v1.2 – Global Health Mental 2a, Timed Up and Go Test; Pain : Numeric Rating Scale, Delirium: 4AT Rapid Test and AMTS at 2 weeks, 6 weeks, 12 weeks, 6 months and 12 months
Sample: Patients aged 60 years or older; a Lateral Compression Type-1 fragility fracture of the pelvic ring, arising from a fall from standing height or less; after 72 hours post-injury, patients who are unable to mobilise independently or with supervision (with or without a walking aid) to a distance of around 3 metres and back due to pelvic pain or perceived pelvic pain.
Recruitment: Overall 600, Oxford 15
Study dates: 1st Nov 2019 to 30th March 2022

WHiTE 5 - The World Hip Trauma Evaluation Five (WHiTE 5)

A randomised controlled trial comparing uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures

Chief Investigator: Matt Costa
Principal Investigator: G Kamborouglou
Research Team: Lerner R; Mironov K; Fernandez M; Achten J; Parsons N Intervention
Uncemented hemiarthroplasty versus cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures
Assessment: Review of complications at 12 months, EQ-5D-5L at 1 and 4 months post-surgery, mortality, mobility and residential status at 1, 4 and 12 months
Sample: 60 years and over with a displaced intracapsular fracture of the hip requiring surgical intervention
Recruitment: Overall 1168, Oxford 136 over 15 months
Study dates: March 2018 - September 2020.

MoHip - Monitoring of Hip Injury Patients

A sub-study embedded in the WHiTE cohort designed to determine the feasibility and acceptability of using wearable activity monitors to track physical activity and other outcomes (e.g., physical pain, fear of falling) after surgery for fragility hip fracture

Research Team: Armitage L; Rutter H Chief Investigator: Matt Costa
Principal Investigator: Andrew Farmer
Intervention: Activity monitor worn around the neck for up to three months
Assessments: EQ5D-5L, symptoms and surgical complications
Sample: Over 60 with a hip fracture which has been fixed operatively and patient is able to comply with study requirements Recruitment: Up to 100 participants Study dates: 16/5/2018 - 1/10 2019

AFTER - Ankle Fracture Treatment: Enhancing Recovery

Optimising mobility after ankle fracture treatment in older adults: a multicentre pilot randomised controlled trial. Qualitative interviews of patient experience and trial participation

Research Team: Lamb S; Costa M; Redmond A; Barber V; Dutton S; Tutton L; Willett K; Dritsaki M
Chief Investigator: David Keene
Principal Investigator: Hannah Perkin
Intervention: Best practice advice versus progressive functional exercise with up to 6 sessions with a physiotherapist
Assessments: Baseline data, 3 month follow-up and 6 month research visit
Sample: Adults over 50 who have fractured their ankle and require surgery or immobilising in a cast for at least 4 weeks
Recruitment: 48 participants (Up to 10 for the interviews)
Study Dates: 01/07/2018 - 31/12/2019

CO-OLLF - Core Outcomes for Research in Open Lower Limb Fractures

Study aiming to develop a core outcome set identifying the important outcomes for patients’ recovery with associated lower limb fractures

Chief Investigator: Alex Aquilina
Research Team: Aquilina A; Griffin X; Costa M; Tutton E; Fitzpatrick R
Methods: Systematic review, focus groups with patients and researchers/clinical staff respectively, an online survey and two consensus meetings
Sample: Patients over 18 years old having previously sustained an open lower limb fracture, healthcare professionals or researchers with previous experience of caring for patients who have sustained a lower limb fracture
Recruitment: Approximately 30 patients and 30 staff
Study dates: August 2018 - December 2018

AceFIT - Acetabular Fractures in older patients Intervention Trial

A feasibility study comparing three methods of treatment of acetabular fractures in older patients

Chief Investigator: Andy Carrothers
Principal Investigator: McMaster, J
Research Team: Queally J; O’Leary R; Marsland L; Bond S
Intervention: Non-surgical conservative treatment versus surgical fixation versus surgical fixation with hip replacement, qualitative interviews of patient experience
Assessment: EQ-4D-5L at 6 months, with Oxford Hip Score, Disability Rating Index, radiographic evaluation
Sample: 60 years and over with displaced acetabular fracture
Recruitment: Overall 60, Oxford 6-18 over 9 months
Study dates: February 2018 - March 2020

ACTIVE - Articular pilon fracture trial

External frame versus internal locking plate for articular pilon fracture fixation in adult patients-a multi-centre randomised controlled trial

Qualitative interviews focusing on patient experience
Research Team: McDaid C; Brealey S; Parker A; Northgraves M; Torgenson D; Giotikas N; Costa M; Barron E
Chief Investigator: Hemant Sharma
Principal Investigator: Xavier Griffin
Intervention: External frame or locking plate
Assessments: Baseline data, 3, 6, 12 and 24 month questionnaires
Sample: 16 years and older with C1, C2 or C3 unilateral distal tibia fractures
Recruitment: 344 patients
Study Dates: 01/09/2017 - 31/08/2022, 12 month feasibility study commencing recruitment 21/06/18
PROFHER 2 - Proximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2 A three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four-part fractures of the proximal humerus in patient over 65 years of age Research Team: Gwilym S; DiMascio L; Danjoux G; Jones V; Kassam J; Torgenson D; Hewitt C; Keding A; Corbacho B; McDaid C; Tharmanathan P; Kottam L; Arundel C; Anderson D Chief Investigator: Amar Rangan Principal Investigator: Stephen Gwilym Intervention: Reverse shoulder arthroplasty versus hemiarthroplasty versus non-operative management and 12 sessions of physio Sample: 60 years and over with three and four part proximal humerus fractures Recruitment: 380 patients Study Dates: 01/07/2018 - 31/12/2019

WHiTE 8 - The World Hip Trauma Evaluation Eight (WHiTE 8) Main Study

A randomised controlled trial comparing low dose, single antibiotic cement versus high dose dual antibiotic loaded cement on the rate of deep infection in patients receiving a cemented hemi-arthroplasty

Chief Investigator: Matt Costa Principal Investigator: Graham Sleat
Research Team: Reed M; Costa M; Wallis S; Crane A; Achten J; Dutton S; Dritsaki M; Agni, N
Intervention: Low dose, single antibiotic loaded cement hemiarthroplasty versus high dose dual antibiotic loaded cemented hemiarthroplasty for the treatment of displaced intracapsular hip fracture
Assessment: Review of antibiotic use at 4 months, EQ-5D-5L at 4 months post-surgery, mortality, antibiotic resistance and mobility 4 months
Sample: 60 years and over with a displaced intracapsular fracture of the hip requiring surgical intervention Recruitment: Overall 4920, Oxford 4 per month over 48 months
Study dates: August 2018 - August 2022

WHITE - World Hip Trauma Evaluation

A baseline cohort study of patients presenting with a hip fracture who are over 60 years old

Chief Investigator: Matt Costa
Principal Investigator: Bob Handley
Research Team: Achten J; Baddick K; Hennings S; Parson N; Petrou S.
Assessments: Lifestyle questions pre injury and at 4 months after surgery and health economics from the National Hip Fracture Database
Sample: Patients who are 60 years old and over who have had surgical fixation for a hip fracture
Recruitment: Aim Oxford 300 a year, overall 6000
Study dates: 19/01/2015 - 01/08/2016 - open extension