Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7762; Protocol Version 5
Study information
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
Acronym
WHiT
Study hypothesis
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
Coventry Research Ethics Committee approved on the 6th of July 2009 (ref: 09/H1210/22)
Study design
Randomised standard-of-care controlled blinded pragmatic clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
The proportion of participants undergoing re-operation for failure of fixation within one year of sustaining the fracture.
Secondary outcome measures
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
Overall trial start date
01/08/2009
Overall trial end date
01/08/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 225; UK Sample Size: 225
Participant 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
Recruitment start date
01/08/2009
Recruitment end date
01/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Peter Hedges
Research Support Services
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Furlong Research Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bupa Foundation (UK) (ref: TBF-M09-026)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20716348
Publication citations
-
Results
Griffin XL, Parsons N, Achten J, Costa ML, Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur. Protocol for the WHiT Study., BMC Musculoskelet Disord, 2010, 11, 184, doi: 10.1186/1471-2474-11-184.