The Warwick Hip Trauma Study
| 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
Scientific
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Study design | Randomised standard-of-care controlled blinded pragmatic clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/08/2009 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 225; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
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" |
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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
