The Warwick Hip Trauma Study

ISRCTN	ISRCTN49197425
DOI	https://doi.org/10.1186/ISRCTN49197425
Protocol serial number	7762; Protocol Version 5
Sponsor	University of Warwick (UK)
Funders	Furlong Research Charitable Foundation (UK), Bupa Foundation (UK) (ref: TBF-M09-026)

Submission date: 23/04/2010
Registration date: 23/04/2010
Last edited: 09/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mathew Costa
Scientific

Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised standard-of-care controlled blinded pragmatic clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur
Study acronym	WHiT
Study objectives	Controversy exists regarding the optimal treatment for patients with displaced intracapsular femoral neck fractures. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We will test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system. 1. That internal fixation with parallel cannulated screws and intra-fracture injection of platelet-rich plasma (PRP) compared with internal fixation alone leads to a reduced incidence of failure of fixation 2. Additionally to explore the size of the effect on the incidence of fixation failure of a fixed-angle system compared with internal fixation with parallel cannulated screws
Ethics approval(s)	Coventry Research Ethics Committee approved on the 6th of July 2009 (ref: 09/H1210/22)
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Osteoporotic and fragility fractures
Intervention	All participants will have a closed reduction of their fracture. The lower limb will be supported on a fracture table. Internal fixation of the fracture will be achieved through a standard lateral approach with perioperative antibiotic cover in accordance with hospital protocol. Post-operative care will include early active mobilisation managed by a standard physiotherapy rehabilitation regime. All participants will have routine prophylaxis against deep vein thrombosis. Participants will be randomised to one of three groups: 1. Fixed-angle screw and plate fixation 2. Standard of care fixation and placebo injection 3. Standard of care fixation and PRP injection Group 1: Fixed-angle screw and plate fixation Fixation will be with the Targon FN Head Preserving System as described in the manufacturer's operative technique manual. Group 2: Standard of care fixation Fixation will be with three parallel cannulated screws. The exact configuration will be left to the discretion of the operating surgeon to ensure the results can be easily generalised. Fixation will be achieved using the standard operative technique. Group 3: Standard of care fixation and PRP injection Fixation will be with three parallel cannulated screws. The exact configuration will be left to the discretion of the operating surgeon to ensure the results can be easily generalised. Each screw will be advanced up to but not beyond the fracture such that no compression is achieved before the test substance is injected. The guidewire of one screw will then be removed and 5ml of PRP will be injected down the cannulated screw directly into the fracture site under image intensifier guidance. The guidewire will be immediately replaced and the screw/s will then be advanced to compress the fracture site. Follow up length: 12 months Study entry: Single Randomisation only
Intervention type	Other
Primary outcome measure(s)	The proportion of participants undergoing re-operation for failure of fixation within one year of sustaining the fracture.
Key secondary outcome measure(s)	1. Radiographic non-union rate at 12 months. Non-union will be defined as "failure of the fracture to show signs of bony union on the anteroposterior or lateral radiograph 1 year after surgery". 2. Radiographic evidence of failure of fixation at 6, 12 and 52 weeks 3. Radiographic evidence of avascular necrosis at one year 4. Magnetic resonance imaging at 6, 12 and 52 weeks. This measure will only be recorded for those participants with capacity to consent. 5. The EQ-5D score at 6, 12 and 52 weeks 6. Length of index hospital stay
Completion date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	225
Key inclusion criteria	1. All patients who present with intracapsular fractures of the proximal femur 2. Male and female, lower age limit of 65 years 3. With or without capacity to consent
Key exclusion criteria	1. All patients who present late following their injury i.e. more than 48 hours after the index fracture 2. Patients with other serious injuries to either lower limb that would interfere with rehabilitation of the index fracture 3. Patients who are managed non-operatively 4. Patients younger than 65 years
Date of first enrolment	01/08/2009
Date of final enrolment	01/08/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Warwick Medical School

Coventry
CV2 2DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/08/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes