Research Studies in Trauma and the Major Trauma Centre

ACTIVE

Articular Pilon Fracture Trial

A multicentre, randomised, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular Pilon fracture fixation in adults.

Chief Investigator: Hemant Sharma
Principal Investigator: Sandy Wood
Intervention: External frame or locking plate
Sample: 16 years and older with C1, C2 or C3 unilateral distal tibia fractures
Recruitment: 344 patients

Articular Pilon Fracture Trial (ACTIVE) - Health Sciences

AFTER

Ankle Fracture Treatment Enhancing Rehabilitation

A multicentre, parallel-group, superiority individually randomised controlled trial assessing the clinical effectiveness of supervised versus self-directed rehabilitation in improving ankle function for people aged 50 years and over after an ankle fracture. Embedded qualitative study.

Chief Investigator: David Keene
Principal Investigator: Warren Sheehan
Intervention: Supervised rehabilitation
Sample: Adult patients aged 50 years and over with ankle fractures
Recruitment: 344 patients

The AFTER Study

The Role of Neuro-inflammation in Morton's Neuroma

To determine the presence of intraneural inflammation in patients with Morton's neuroma compared to healthy controls.

Chief Investigator: Annina Schmid
Principal Investigator: Dominic Furniss
Sample: 60 patients with Morton's neuroma, 47 control participants for neural tissue and 47 control participants for sensory testing/MR neurography
Recruitment: 154

AOCPP

Linking of PROMIS® measures to legacy measures in an orthopaedic patient population
Defining the Recovery Trajectory using Patient Reported Outcomes Measurement Information System (PROMIS®) to Optimize Decision-making and Outcomes following Extremity Fractures.

An observational cohort study of recovery outcomes from injury post-surgery, or post non-surgical treatment using questionnaires.

Chief Investigator: Prakash Jayakumar
Principal Investigator: Warren Sheehan
Sample: Patients aged 18 years and over with an extremity fracture
Recruitment: 400 patients

CRAFFT

Children's Radius Acute Fracture Fixation Trial

A multi-centre prospective randomised non-inferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children. Embedded qualitative study.

Chief Investigator: Daniel Perry
Principal Investigator: Charlotte Brown
Intervention: Surgery or non-surgical casting
Sample: Children aged 4 to 10 years old, inclusive with evidence of a severely displaced radius fracture
Recruitment: Minimum of 750 patients (ensuring there are at least 200 patients with a 'completely off-ended' fracture)

The CRAFFT Study

DIDACT

DIsplaced DistAl Clavicle Trial - DIDACT

Surgery versus sling immobilisation in the management of adults with a displaced fracture of the distal clavicle: a multi-centre, pragmatic, parallel group, non-inferiority, randomised controlled trial.

Chief Investigator: Harvinder Singh
Intervention: Surgery a locking plate fixation, with or without a coracoclavicular (CC) sling, or CC reconstruction alone when the distal fragment is very small.
Sample: Adults with a radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint.
Recruitment: 214 patients (107 in each group)

DIDACT - South Tees Hospitals NHS Foundation Trust

DRAFT3 - CASP

Distal Radius Acute Fracture Trial - Cast-v-Splint

Multicentre, randomised, non-inferiority trial of cast versus splint for a wrist fracture. Embedded qualitative study.

Chief Investigator: Matthew Costa
Intervention: Plaster cast-v-removable splint
Sample: Distal radius fractures in adults that are undisplaced and do not require surgery.
Recruitment: 1,894 patients

The DRAFT3-CASP Study

FAME

Fractured Ankle Management Evaluation

Multi-centre, parallel, two arm, randomised non-inferiority clinical trial in younger adults to determine whether functional outcomes at 4 months are not worse in people with unstable ankle fractures treated with close contact casting than in those treated with surgical intervention.

Chief Investigator: Xavier Griffin
Principal Investigator: Sandy Wood
Intervention: Close contact casting or surgical fixation
Sample: Adult patients, aged 18 to 60 years inclusive, with an unstable ankle fracture
Recruitment: Aim to recruit 890 patients across all sites

FAME - NDORMS

FIRST

Flexor Injury Rehabilitation Split Trial

Prospective randomised controlled trial comparing three splints for finger flexor tendon repairs.

A parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial.

Chief Investigator: Emma Bamford
Local Investigator: Anne Alexander
Sample: Patients undergoing rehabilitation following the surgical repair of zone I/II flexor tendons will be recruited to the study.
Recruitment: 429 patients

First Study - Pulvertaft Hand Centre

HUSH

The Humeral Shaft Fracture Trial

The aim of this pragmatic randomised controlled trial is to evaluate the clinical and cost-effectiveness of functional bracing, compared to surgical fixation for the treatment of humeral shaft fractures.

Chief Investigator: Steve Gwilym
Principal Investigator: Andrew Titchener
Intervention: Surgical fixation versus functional brace
Sample: Adult patients aged 18 years and older with a fracture of the humeral shaft (diaphysis)
Recruitment: 334 patients

HUSH - The Humeral Shaft Fracture Trial

PRePPeD

Physiotherapy Rehabilitation Post Patellar Dislocation

Multicentre, parallel, two-arm, external pilot randomised controlled trial. Supervised versus self-managed rehabilitation for people after acute patellar dislocation.

Chief Investigator: Colin Forde
Principal Investigator: Georgina Taylor
Intervention: Supervised rehabilitation (four to six physiotherapy sessions) versus self-managed rehabilitation (one physiotherapy session).
Sample: Patients aged 14 years and older with an acute first-time or recurrent patellar dislocation
Recruitment: 50 participants

Rehabilitation Post Patellar Dislocation

RESULT-Hip

The impact of REStrictive versUs LIberaL Transfusion strategy on cardiac injury and death in patients undergoing surgery for Hip Fracture (RESULT-Hip).

A multicentre randomised controlled trial comparing the effect of two perioperative transfusion strategies on the incidence of death and cardiac injury after emergency hip fracture surgery.

Chief Investigator: Michael Gillies
Principal Investigator: Shvaita Ralhan
Intervention: Blood Transfusion: Liberal vs Restrictive
Assessment: Blood samples, Demogaphic data, 4 AT, EQ5D
Sample: Adults aged 60 years or over & admitted to hospital for operative management of hip fracture
Recruitment: 1964 participants across all 30 sites, 982 for each arm

RESULT-HIP - The University of Edinburgh

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 to quantify and draw inferences on observed differences in function using the Patient Reported Outcomes Measurement Information System (PROMIS).

Upper Extremity Score. Embedded qualitative study.

Chief Investigator: Dan Perry
Principal Investigator: Mark Deakin
Intervention: Cast/splint or operative treatment
Sample: 7-15 years with a medial epicondyle fracture (elbow) of the humerus (upper arm)
Recruitment: 334 patients

SCIENCE Study

WHiTE10 - LIT

Lidocaine Intravenous Trial (LIT)

Pragmatic, multicentre, two-arm randomised superiority comparison with parallel economic analyses follow-up to one year.

Chief Investigator: Matthew Costa
Principle Investigator: Jo White
Intervention: Intravenous lidocaine verus intravenous saline (placebo) for the duration of surgery
Sample: Adults aged 60 years and over with a hip fracture, who in the opinion of the treating surgeon may benefit from surgical treatment and meet LIT specific eligibility criteria
Recruitment: 416 patients

WHiTE10 - NDORMS

WHiTE 11 - FRUITI

World Hip Trauma Evaluation - Fix or Replace Undisplaced Intracapsular Fractures

A pragmatic, multicentre, randomised superiority clinical trial with parallel economic analysis with direct participant follow-up to one year. Looking at health-related quality-of-life between internal fixation (sliding hip screw or cannulated screws) and hip replacement (hemiarthroplasty and total hip arthroplasty).

Lead Investigator: Xavier Griffin
Principle Investigator: Matthew Costa
Sample: Adults aged 60 years and over with a hip fracture, who in the opinion of the treating surgeon may benefit from surgical treatment and meet the specific FRUITI eligibility criteria.
Recruitment: 878 patients

FRUITI - NDORMS

WHiTE 14 - PRESSURE3

Pressure ulcer prevention 3: A randomised clinical trial assessing early heel specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip.

Pragmatic, multicentre, randomised, three-arm parallel group comparison with embedded economic evaluation.

Chief Investigator: Jane Nixon/Matthew Costa
Principle Investigator: Julie Wright
Sample: Adults aged 60 years and over admitted with a hip fracture within previous 48 hours that in the opinion of the treating clinical team may benefit from surgical treatment. Patients who lack capacity may be entered into the comparison under a pre-specified representative agreement process.
Intervention: Standard care plus low pressure devices versus standard care plus heel off-loading devices for up to 30 days or hospital discharge
Recruitment: 3,102 patients

WHITE-PRESSURE3 - NIHR

ICECAP

Inflammation and fibrosis: Causes in adhEsive CAPsulitis

Laboratory investigations into frozen shoulders.

Chief Investigator: Andrew Carr
Principal Investigator: Stephanie Dakin
Research Team: Dominic Furniss, Amar Rangan, Kim Wheway, Bridget Watkins, Lucksy Kottam, at John Radcliffe, Kathryn Lewis, Maria Mestre, Sangeetha Prasath, Tessa Sewdin
Intervention: The study is a multi-centred prospective, observational and laboratory study to evaluate the tissue changes that take place in adhesive capsulitis commonly called a frozen shoulder
Assessment: Outcome measures OSS (Oxford Shoulder Score – pain and function) and SPADI (Shoulder Pain and Disability Index – pain and function) scores during routine attendance for pre-operative hospital visit in addition to venous blood sampling and tissue biopsy during their elective surgical procedure
Sample: Patients with frozen shoulder undergoing elective surgery
Recruitment: Aim to recruit 85 patients
Study dates: 15/11/2018 - 01/12/2022

Dakin Group | Soft Tissue Joint Disease - NDORMS