Condition category
Musculoskeletal Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
09/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mathew Costa

ORCID ID

Contact details

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

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 measures

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

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

http://www2.warwick.ac.uk

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

foundation

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20716348

Publication citations

  1. 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.

Additional files

Editorial Notes