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Research studies in progress in the Major Trauma Centre

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

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: 16/05/2018 – 31/12/2018

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 7 - Wound Healing in Surgery for Hip fractures (WHISH)

A feasibility randomised control trial comparing 2 types of wound dressing in patients undergoing surgery for a fractured hip

Chief Investigator: James Masters
Principal Investigator: John McMaster
Research Team: Samson L; Costa M; Achten J; Cook J.
Assessments: To assess differences in rate of deep infection in the hip at 30 days after hip fracture surgery. Patients are also included in the WHiTE study where the same assessments will be undertaken
Sample: Patients who are 65 years old and over who require surgical fixation for hip fracture
Recruitment: Overall 464, Oxford 120
Study dates: 19/09/2017 - 19/03/2018

WOODCAST: Woodcast vs standard casting material for the immobilisation of wrist fracture treated non-operatively

A randomised feasibility study

Chief Investigator: Stephen Gwilym
Research Team: Samson L
Intervention: Woodcast vs standard casting material
Assessment: Patient rated wrist evaluation, EQ5D-5L, radiographic evaluation, baseline and 3 months
Sample: Over 16 years with wrist fracture
Recruitment: Overall 120 Oxford 60
Study dates: 19 June 2017 - 28 February 2018

DRAFFT2: Distal Radius Acute Fracture Fixation Trial 2

Chief Investigator: Matthew Costa
Principal Investigator: Stephen Gwilym
Research Team: Lamb S; Achten J; Haywood D; Dritsaki M; Mironov K; Campolier M; Cook J; Scones W; Sansom L.
Intervention: Moulded plaster cast versus metal wires (K wires)
Assessments: Patient rated wrist evaluation and EQ5D-5L at 6 weeks 3, 6, and 12 months
Sample: Over 16 years old with a wrist fracture (dorsally displaced distal radius)
Recruitment: Overall 476
Study dates: January 2017 - September 2018

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/drafft-2

TrAFFix Trial of Acute Femoral Fracture Fixation: A feasibility study

Chief Investigator: Xavier Griffin
Principal Investigator: David Noyes
Research Team: Lerner R; Achten J; Lamb S; Dritsaki M; Costa M.
Intervention: Two different types of metal work to fix a fracture in the lower end of the thigh bone
Assessments: Questionnaires at baseline and 4 months, plus a process evaluation
Sample: Patients 50 and older who require surgical fixation for a fracture of the distal femur
Recruitment: Overall 52
Study dates: August 2016 - May 2017

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

UKSTAR Study of Tendo Achilles Rehabilitation

UKSTAR: UK Study of tendo Achilles Rehabilitation – multicentre randomised clinical trial

Chief Investigator: Matt Costa
Research Team: Liew A; Achten J; Haywood D.
Intervention: Functional bracing versus plaster cast for patients with a ruptured Achilles tendon that does not require surgery
Assessments: Questionnaires at baseline, 8 weeks (plus clinical assessment), 3, 6 and 9 months post injury
Sample: 330
Recruitment: Not recruiting in Oxford until 2017
Study dates: July 2016 - May 2018

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

PATH2 - Platelet rich Plasma in Achilles Tendon Healing

A multi-centre, blinded, randomised placebo controlled trial comparing a Platelet Rich Plasma (PRP) injection to a placebo (imitation) injection in adults with Achilles tendon rupture. Two sub-studies are included within the main study to contribute to the understanding of the PRP mechanism in tendon healing

Chief Investigator: Keith Willett
Principal Investigator: Bob Handley
Research Team: Alsousou J; Lamb S; Harrison P; Hulley P; Dutton S; Keene D; Morgan L.
Intervention: Platelet Rich Plasma injection (PRP) or placebo (imitation) injection
Assessments: Baseline data, 3, 7, 13 and 24 week questionnaires and 24 week heel endurance test
Sample: 18 and above years old with an Achilles tendon rupture which is being treated non-operatively
Recruitment: Aim Oxford 17, overall 214
Study dates: 18/06/2015 - 18/09/2017

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/path-2

WHiTE 4 - World Hip Trauma Evaluation four

A randomised control trial comparing 2 types of surgical fixation for a hip fracture with a specific fracture pattern

Chief Investigator: Xavier Griffin
Principal Investigator: Bob Handley
Research Team: Wallis S; Costa M; Achten J.
Assessments: Lifestyle questions pre injury and at 4 months after surgery, secondary outcomes are mortality, functional status, revision surgery and cause plus complications
Sample: Patients who are 60 years old and over who require surgical fixation for an intertrochanteric hip fracture
Recruitment: Aim 140, overall 964
Study dates: 15/06/2016 - 01/12/2017

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

WHiST - Wound Healing in Surgery for Trauma

A randomised control trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb

Chief Investigator: Matt Costa
Principal Investigator: Xavier Griffin
Research Team: Achten J; Spoors L; Nanchahal J; Haywood D; Dritsaki M.
Assessments: Lifestyle questions pre injury and at 1, 3, 6, 12 months and at 2, 3, 4 and 5 years. Photographic record of wound at 30 days
Sample: Patients who are 16 years old and over who present with major trauma injury to the lower limb
Recruitment: Aim Oxford 125, overall 1540
Study dates: 07/07/2016 - 31/12/2018

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

SCI-POEM - Spinal Column Injury - Prospective, Observational European Multicentre Study

Chief Investigator: Giuseppe Barbagallo
Principal Investigator: Jeremy Reynolds
Research Team: Hosman A; Barbagallo G; van Middendorp JJ.
Observational study: Early compared with late surgical stabilisation (>12 hours) in patients who have experienced a traumatic spinal column injury
Assessments: Baseline, day 3, discharge, 3, 6 and 12 month ASIA scores which assess the extent of the spinal cord injury
Sample: 18 years old and over with blunt spinal column injury and spinal cord injury
Recruitment: Overall 300
Study dates: 28/02/2015 - 31/12/2018

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