Research studies in the Major Trauma Centre

Studies in progress

Updated May 2021

ACTIVE

Articular Pilon Fracture Trial

A multi-centre, 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: Xavier Griffin
• Intervention: External frame or locking plate
• Sample: 16 years and older with C1, C2 or C3 unilateral distal tibia fractures
• Recruitment: 344 patients

ACTIVE – York Trials Unit

ARTISAN

Acute Rehabilitation Following Traumatic Anterior Shoulder Dislocation

A multi-centre randomised controlled trial with health economic evaluation, to find out if a course of physiotherapy is of clear benefit when compared to a single session of advice.

• Chief Investigator: Rebecca Kearney
• Principal Investigator: Warren Sheehan / Steve Gwilym
• Intervention: Single session physiotherapy advice for all, intervention of a second physiotherapy session and guided internet-based exercises
• Sample: 18 years and over with a first-time anterior shoulder dislocation
• Recruitment: 478 patients (Oxford 16)

ARTISAN - Warwick Clinical Trials Unit

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.

• Chief Investigator: Daniel Perry
• Principal Investigator: Jiske Steensma
• 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)

CRAFFT website

COSTA

Core Outcome Set for Fractures of the Distal Tibia and Ankle

Through interviews and focus groups, this study seeks to produce a long list of outcome domains that capture what is important to and matters for both patients and healthcare professionals.

• Chief Investigator: Kirstie Haywood
• Principal Investigator: Steve Gwilym / Liz Tutton
• Intervention: Semi-structured interviews
• Sample: Interviews with up to 30 patients and up to 4 focus groups with up to 6 participants (healthcare professionals) in each
• Recruitment: 20 patients

FAME

Fractured Ankle Management Evaluation

Multi-centre, parallel, two arm, randomised non-inferiority clinical trial in younger adults to determine whether functional outcomes at four 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

HIPGEN

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
• Intervention: Intramuscular injection of stem cells for muscle injury following hip surgery
• Sample: Adult patients, aged 60 to 90, who have had a low-energy trauma with intracapsular neck of femur fracture, planned to be treated with a total hip arthroplasty or hemi-arthroplasty
• Recruitment: 240 patients (Oxford 20)

HIPGEN website

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 - NDORMS

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 non-surgical treatment.

• Chief Investigator: Peter Bates (Barts Health NHS Trust)
• Principal Investigator: David Noyes
• Intervention: Anterior internal surgical fixation device or non-surgical management
• 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
• Recruitment: 600 patients (Oxford 15)

L1FE - York Trials Unit

NEON

Digital Nerve, Suture Or Not

A randomised controlled trial to assess if microsurgical nerve repair offers clinical benefit and cost effectiveness (in terms of patient reported hand function, sensory recovery and adverse events) over exploration and washout without microsurgical nerve repair.

• Chief Investigator: Abhilash Jain
• Principal Investigator: Dominic Furniss
• Intervention: Digital nerve surgery with microsurgical sutures verses digital nerve surgery with realignment of nerve ends but no microsurgical sutures
• Sample: Patients aged 18 and over presenting with a single traumatic unilateral digital nerve injury appropriate for surgical repair
• Recruitment: 478 patients (239 in each treatment arm)

NEON - OCTRU

PINS

Pain in Neuropathy Study

A single cohort, cross sectional phenotyping/genotyping study, designed to look at the changes in tissues (e.g. inflammation and cellular changes) occurring as a consequence of having carpal tunnel syndrome and associated neuropathic pain, investigating patients having hand surgery, without carpal tunnel.

• Chief Investigator: David Bennett
• Principal Investigator: Anina Schmid
• Sample: Patients aged 18 years or older who have a diagnosis of a peripheral neuropathy (based on prior clinical assessment and supportive investigations), without central nervous lesions
• Recruitment: Oxford 10 patients

POINT

Proximal Phalanx Shaft Finger Fractures

A multi-centre randomised trial to determine the clinical and cost-effectiveness of surgery compared to non-surgical splint treatment for Proximal Phalanx Shaft (PPS) finger fractures in adults.

• Chief Investigator: Alexia Karantana
• Principal Investigator: Michelle Spiteri
• Intervention: Surgery versus non-surgical treatment
• Sample: Patients aged 16 or over with one or more PPS finger fracture(s), with the injury less than 14 days old
• Recruitment: 400 patients
  

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.

• 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 fracture
• Recruitment: 380 patients (Oxford 18)

PROFHER-2 - York Trials Unit

PTRON

Primary Tumour and Research Outcome Network

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
• Sample: Patients with a current primary spine tumor of history of a primary spine tumor, including tumors within or surrounding the spinal column/cord, aged 13 and over
• Recruitment: Initial aim - 100 patients

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.

• 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 website

SOFFT

Suture Olecranon Fracture Fixation Trial

A multi-centre randomised controlled trial, to investigate the clinical and cost-effectiveness of tension suture repair versus tension band wiring.

• Chief Investigator: Adam Watts
• Principal Investigator: Andrew Titchener
• Intervention: Suture fixation versus tension band wiring
• Sample: Patients aged 16 years and older with a clinical diagnosis of a Mayo Grade IIA acute olecranon fracture requiring surgical fixation
• Recruitment: 280 patients

SOFFT - York Trials Unit

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
• Sample: Patients who are 60 years old and over who have had surgical fixation for a hip fracture
• Recruitment: 6000 patients (Oxford 300 per year)

WHITE - NDORMS

WHITE 8

The World Hip Trauma Evaluation Eight

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
• Intervention: Low dose, single antibiotic loaded cement hemiarthroplasty versus high dose dual antibiotic loaded cemented hemiarthroplasty
• Sample: 60 years and over with a displaced intracapsular fracture of the hip requiring surgical intervention
• Recruitment: 4920 patients (Oxford 4 per month over 48 months

WHITE 8 - NDORMS

WHITE 9 - BEST

The World Hip Trauma Evaluation Nine; Blood CEll Salvage and AutoTransfusion Feasibility Study

A feasibility randomised controlled trial comparing intra operative washed cell salvage and autotransfusion with standard care for the treatment of hip fractures.

• Chief Investigator: Damian Griffin / Xavier Griffin
• Principal Investigator: Jowan Penn-Barwell
• Intervention: Intra operative washed cell salvage and autotransfusion (collecting the patient's own blood and transfusing it back to them)
• Sample: Participants of 60 years of age and older who have sustained a fracture of the hip who, in the opinion of the operating surgeon, would benefit from surgery
• Recruitment: Aim to recruit 96 patients

WHITE 9 - NDORMS

WISE

Wrist Injury Strengthening Exercise

A randomised multicentre feasibility study of flexibility and resistance exercises versus usual care for improving pain and function after distal radius fractures.

• Chief Investigator: David Keene
• Principal Investigator: Colin Forde
• Intervention: Independent exercise versus supervised exercise in additional to usual care versus usual care
• Sample: Patients 50 years and over with an acute distal radius fracture
• Recruitment: 72 patients

WISE - NDORMS