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Research studies taking place in the Major Trauma Centre

Lead site

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 - May 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

Contributing site for recruitment

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 - extended November 2016

Lead site in follow-up

AIM: Ankle Injury Management

A pragmatic multi-centre randomised controlled trial comparing close contact cast technique to open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years
Chief Investigator: Keith Willett
Principal Investigator: Bob Handley
Research Team: Keene, D; Lamb, S; Pallister, I; Chesser, T; Handley, R; Tutton, E; Mistry D; Nam J; Morgan L; Roberts E; Briggs A; Lall R
Intervention: Close Contact Cast or Open Reduction and Internal Fixation.
Assessments: Baseline data, 6 week and 6 month, up to 5 year follow up.
In addition 36 interviews 6 -10 weeks post injury
Sample: Over 60 years of age with displaced unstable fracture of the ankle
Recruitment: Oxford 95 (AS04) + 42(AIM), overall 620
Study dates: July 2001 - December 2013
Extended follow: 01/12/16

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

SPRAINED: Synthesising a clinical Prognostic Rule for Ankle INjuries in the Emergency Department

Chief Investigator: Sallie Lamb
Principal Investigator: Phillip Hormbrey
Research Team: Keene, D; Thompson, J; Byrne, C; Hagan, D; Bostock, J; Collins, G; Cooke, M; Goodacre, S; Wilson, D; Williams, M, Gwilym, S; Hormbrey, P.
Observation Study: To develop a tool that can predict recovery from ankle sprain and test the tool in emergency departments in the UK
Assessments: Questionnaires at baseline, 4 weeks and 9 months
Sample: Adults with an acute ankle sprain presenting to an emergency department
Recruitment: Oxford 82, overall 682
Study dates: 13/07/2015 - 17/03/2016
Follow-up: 10/12/16

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

Contributing site for studies now in follow-up

SWIFFT - Scaphoid Waist Internal Fixation for Fractures Trial

A multi-centre randomised controlled trial looking at two different ways of treating a fracture of the scaphoid bone in the wrist
Chief Investigator: Joe Dias
Principal Investigator: Ian McNab
Research Team: Dias J; Brealey S; Jefferson L; Shah S; Cook L; Tew G.
Intervention: Cast treatment for 6-10 weeks or surgical fixation with a specialised screw
Assessments: Baseline, 6 weeks, 3, 6, 12 months and 5 years involving questionnaires, X-rays and measurements of hand and wrist function
Sample: Over 16 years of age with a scaphoid waist fracture
Recruitment: Oxford 35, overall 438
Study dates: 01/02/2014 - 26/July/2016
Extended follow-up: 31/07/2021

FIXDT - FIXation of Distal Tibia Fracture

A multi-Centre randomised controlled trial looking at two different ways of fixing a distal tibia fracture
Chief Investigator: Matt Costa
Principal Investigator: David Noyes
Research Team: Costa M; Achten J; McGuiness K; Hennings S; Parsons N; Dritaski M; Lamb S.
Intervention: Locking plate fixation or intramedullary nail fixation
Assessments: Baseline, 6 weeks, 3, 6, 12 month questionnaires then optional annual questionnaire
Sample: 16 years old and over with a fracture involving the distal tibia
Recruitment: Oxford 15, overall 320
Study dates: 01/03/2013 - 28/04/2016
Follow-up: 28/04/2017

WoLLF - Wound Management of Open Lower Limb Fractures

A Randomised Controlled Trial of standard care wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb
Chief Investigator: Matt Costa
Principal Investigator: David Noyes
Research Team: Costa M; Achten J; Lamb S; Willett K; Petron S; Gates S; Jeffery S; Griffin D; Tutton E; Bruce J.
Intervention: Standard Dressing or Negative Pressure Wound Therapy
Assessments: Baseline data, 6 week, 3, 6, 9 and 12 month follow up
Sample: Over 16 years of age with an open fracture of the lower limb
In addition 20 interviews and a focus group
Recruitment: Oxford 44, overall 460
Study dates: 10/12/2012 - 10/12/2015 - follow up 30/09/2016

OVIVA - Oral versus Intra Venous Antibiotics for patients with bone infection.

An open label multicentre randomised control trial for adults who require prolonged antibiotic treatment (6 weeks) for bone and joint infection
Chief Investigator: Matthew Scarborough
Research Team: Philip Bejon
Intervention: Strategies of antibiotic prescribing (oral vs IV) for a period of 6 weeks
Assessments: Baseline data, day 14, 42, 120, 365 follow up questionnaires
Sample: Over 18 years of age with a clinical syndrome and bone and joint infection
Recruitment: 01/04/2013 - 01/04/2017

Closed studies

WaLLTR - Wales Lower Limb Trauma Recovery Scale

Phase 4 of this study is part of a larger observational assessment of surgical and functional outcomes in patients who have sustained open fractures of the lower leg
Chief Investigator: Ian Pallister
Principal Investigator: Keith Willett
Research Team: Trickett R; Price P; Mudge L.
Observational Study: The aim of this study is the development of a novel patient important outcome recovery scale for use in lower limb trauma
Assessments: Baseline, 6 weeks, 3, 6, 9 and 12 month questionnaires
Sample: Over 18 years of age with open fracture of the tibia
Recruitment: Oxford 20
Study dates: 05/10/2015 - 18/07/2016

MaTOMS: Major Trauma Outcome Measures (Lead site)

A feasibility study into the validity and acceptability of routine collection of outcome data in major trauma patients in a Major Trauma Centre in England
Chief Investigator: Sallie Lamb
Research Team: Willett, K; Sleat, G; Tutton, E; Symonds, S; Spoors, L.
Observational Study: Comparison of a range of outcomes over time
Assessments: Discharge, 6 and 12 months, in addition interviews with patients and staff
Sample: Patient admitted with a New Injury Severity score of 9 or more
Recruitment: 70
Study dates: 01/04/2013 - 30/10/2016

ExHIP -Experiences of Hip Fracture (Lead site)

Understanding patient and relative/carer experience of hip fracture in acute care: a qualitative study
Research Team: Debbie Langstaff, Keith Willett
Chief Investigator: Liz Tutton
Principal Investigator: Lorena Saletti-Cuesta
Study: Explores the early phase of the hip fracture experience of patients and their carers taking into account underlying factors such as gender, aging and memory loss
Sample: Interviews and observations with up to 40 patients over 60 years old and 30 relatives/carers
Recruitment: 25 patient interviews, 11 observation sessions with patients, 25 interviews with carers
Study dates: 01/09/2015 - 01/09/2016

Fracture Free Study

To extend understanding of the causes and consequences of fragility fracture - predictors and costs of re - fracture
Chief Investigator: Kassim Javaid
Research Team: Judge, A; Prieto-Alhambra, D; Cooper C; Turner, A; Shah, A; Lang, G.
Observational Study: Patient outcomes at 3 months, 6 months and 12 months
Sample: Over 50 years of age with a fragility fracture, excluding skull, digits, scaphoid
Recruitment: Overall 3000
Study dates: 01/05/2012 - 01/05/2016

FAB - Fractures and Bisphosphonates

A double blind randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures
Chief Investigator: Stuart Ralston
Principal Investigator: Dr Claire Pulford
Research Team: Bucukoglu M; Tuck C; Murray G.
Intervention: 1 tablet a week - either alendronic acid or placebo for 24 weeks
Assessments: Baseline data, randomisation and commence study data within 2 weeks of fracture. Follow up at 2, 4, 6, 8 and 26 weeks, with telephone assessment at weeks 16 and 24
Sample: Over 50 with a distal radius fracture
Recruitment: Oxford 36, overall 421
Study dates: 01/06/2013 - 30/04/2015
Extended follow-up: 01/01/2016

ICUROS - International Costs and Utilities Related to Osteoporotic Fracture Study

An international study to evaluate the health effects and costs associated with osteoporotic fractures
Chief Investigator: McCloskey E.
Principal Investigator: Keith Willett
Observational study: Assessments, baseline data, 4, 12 & 18 month follow up
Sample: Over 50 years old with osteoporosis related fracture of hip, wrist or humerus
Recruitment: Oxford 120
Study dates: 23/03/2010 - 30/04/2015

SAFER - Supports for Ankle Fractures in Early Rehabilitation (Lead site)

A randomised study into the effects of different ankle supports after surgery for ankle fracture in adults
Chief Investigator: Keene D
Research Team: Willett K; Lamb S
Intervention: Three types of ankle support (Walker boot, Stirrup brace and Tubigrip)
Assessment: Walking quality and pain in each ankle support at weight bearing stage at approximately 6 weeks after surgery
Sample: Over 18 years of age with an unstable Weber A or B isolated ankle fracture
Recruitment: 18
Study dates: 01/07/2012 - 01/06/2013

Time Critical Intervention (Lead site)

Early prediction of multiple organ failure following major trauma
Chief Investigator: Lynn Hutchings
Research Team: Watkinson, P; Young, D; Willett, K.
Observational: Retrospective data analysis from multiple hospital data systems
Sample: Major trauma patients meeting TARN entry criteria and requiring ICU admission
Study dates: 01/012013 - 01/04/2015

PATH - Platelet rich plasma in Achilles tendon healing (Lead site)

A feasibility study of Platelet Rich Plasma (PRP) injection in adults with Achilles tendon rupture. Sub-studies are included to contribute to the understanding of the PRP mechanism in tendon healing
Chief Investigator: Joseph Alsousou
Research Team: Willett K;
Intervention: Platelet Rich Plasma injection
Assessments: Baseline data, 3, 6, 13 and 24 week questionnaires and 24 week heel endurance test
Sample: 18-70 years old with an Achilles tendon rupture which is being treated non-operatively
Recruitment: 20
Study dates: 01/02/2010 - 01/01/2011

PRO-Hip Patient reported outcomes following traumatic hip fracture

Chief Investigator: Jo Brett
Principle Investigator: Liz Tutton
Research Team: Haywood, K, Staniszewska, S, Tutton, L. (RCNRI, University of Warwick)
Study: Systematic review and interview with patients at 3 months, focus groups with staff
Sample: Over 60 years of age with traumatic hip fracture
Recruitment: 24
Study dates: 01/05/2012 - 01/03/2013

FRACTT - Functional recovery after Pertrochanteric Fracture treated with Parathyroid Hormone

A Randomised Controlled Trial of parathyroid hormone versus standard osteoporosis care in the functional recovery following petrochanteric fractured neck of femur
Chief Investigator: Tim Chesser
Research Team: Fox R; Harding K; Willett K; Lamb S.
Principal Investigator: Dr Kunal Shah
Intervention: 42 doses of 20micrograms of teriparatide injection or standard osteoporosis care
Assessments: Baseline data, 6, 12 weeks, 6, 12 month follow up
Sample: Over 60 years of age with pertrochanteric hip fracture and fixation with either Dynamic Hip Screw or IM Nail
Recruitment: Oxford 4
Study dates: 01/07/2012 - 01/03/2013

DRAFFT - Distal Radius Acute Fracture Fixation Trial

A Randomised Controlled Trial comparing Open Reduction and Internal Fixation (ORIF) versus Kirschner Wires for unstable dorsally angulated distal radius fracture.
Chief Investigator: Matt Costa
Research Team: Achten J; Lamb S; Parsons N; Brown J; Gaymer C.
Principal Investigator: Keith Willett
Intervention: Volar Locking Plate or Kirschner wire fixation
Assessments: Baseline data and 6 week and 12 month follow up
Sample: Over 50 years of age with low trauma fracture
Recruitment: Oxford 23
Study dates: 01/07/2010 - 04/02/014

AS04 - Ankle Study of Fracture Treatment in the Older Patient (Lead site)

A pragmatic randomised controlled trial comparing close contact cast technique to open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients over 60 years
Chief Investigator: Keith Willett
Principle Investigator: Bob Handley
Intervention: Close Contact Cast or Open Reduction and Internal Fixation
Assessments: Baseline data, 6 week and 6 month
Sample: Over 60 years of age with displaced unstable fracture of the ankle
Recruitment: 95
Study dates: 01/5/2004 - 01/07/2010

WaLLTR - Wales Lower Limb Trauma Recovery Scale

Phase 3 of this study is part of a larger observational assessment of surgical and functional outcomes in patients who have sustained open fractures of the lower leg
Chief Investigator: Ian Pallister
Principal Investigator: Keith Willett
Research Team: Trickett R; Price P; Mudge L.
Observational Study: The aim of this study is the development of a novel patient important outcome recovery scale for use in lower limb trauma
Assessments: Piloting of tool with patients on the wards and in the clinic setting
Sample: Aged 16-80 years of age with open fracture of the tibia
Recruitment: Oxford 50
Study dates: 01/08/2011 - 31/07/2012

The PROFHER trial

Proximal fractures of the humerus: evaluation by randomisation
Chief Investigator: Amar Rangan
Principal Investigator: Keith Willett
Research Team: Stephen Brealey
Intervention: Surgical versus non-surgical intervention for fractures of the top end of the upper arm (proximal humerus)
Assessments: Questionnaires at baseline, 3 and 6 months, 1 and 2 years post injury
Sample: Aged 18 and above, with open fracture of the proximal humerus
Recruitment: Oxford 3
Study dates: 01/09/2009 - 01/03/2012

YUMMY Comparison of oral nutritional supplements

A study of the liking of nutritional sip feeds in individuals lacking capacity and how this correlates with consumption
Chief Investigator: Margot Gosney
Observational Study: To determine the liking of oral nutritional supplements and if this is related to amount consumed
Assessments: Rating of supplements and monitoring amount consumed
Sample: Older people including those with cognitive impairment
Recruitment: 10
Study dates: 2011

SCRATCH Self cast removal at the child's home (Lead site)

A randomised controlled trial to assess the treatment of stable upper limb fractures in children, comparing traditional ridged casts with flexible casts suitable for home removal by the patient
Chief Investigator: Keith Willett
Research Team: Hamilton T.W; Hutchings L; Alsousou J; Tutton E; Hodson E; Smith C.H. Wakefield J; Gray B; Symonds S; Willett K.
Observational Study: Plaster of Paris or fibreglass ridged cast versus home removable flexible cast taken off at home
Assessments: Questionnaires at the clinic visit, 1 week after cast removal and 6 months
Sample: Stable upper limb fracture aged between 2-16 years old
Recruitment: 326
Study dates: 20/02/2008 - 06/12/2010

STARTT Study to assess healing of repaired tibias with sclerostatin antibody

A multicentre, randomised, double blind, placebo-controlled study of AMG785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status post definitive fracture fixation with an intramedullary nail
Principal Investigator: Keith Willett
Intervention: Use of drug to promote healing, injections 96 hours after surgery, 2, 6 and 12 weeks
Assessments: Range of outcomes at 15 time points after initial injection
Sample: 18 or over with a tabial fracture
Recruitment: No recruits due to intensity of treatment and follow up
Study dates: 01/02/2010 - 01/09/2011