ISRCTN ISRCTN49197425
DOI https://doi.org/10.1186/ISRCTN49197425
Secondary identifying numbers 7762; Protocol Version 5
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

Study designRandomised standard-of-care controlled blinded pragmatic clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur
Study acronymWHiT
Study objectivesControversy 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) studiedTopic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Osteoporotic and fragility fractures
InterventionAll 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 typeOther
Primary outcome measureThe proportion of participants undergoing re-operation for failure of fixation within one year of sustaining the fracture.
Secondary outcome measures1. 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 study start date01/08/2009
Completion date01/08/2011

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned Sample Size: 225; UK Sample Size: 225
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2009
Date of final enrolment01/08/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Medical School
Coventry
CV2 2DX
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

c/o Peter Hedges
Research Support Services
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom

Website http://www2.warwick.ac.uk
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Charity

Furlong Research Charitable Foundation (UK)

No information available

Bupa Foundation (UK) (ref: TBF-M09-026)
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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