Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH): a multi-centre randomised trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures
| ISRCTN | ISRCTN25524122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25524122 |
| ClinicalTrials.gov number | NCT00761813 |
| Secondary identifying numbers | MCT-87771 |
- Submission date
- 13/06/2008
- Registration date
- 13/06/2008
- Last edited
- 21/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohit Bhandari
Scientific
Scientific
McMaster University
293 Wellington Street North
Suite 110
Hamilton, Ontario
L8L 8E7
Canada
| Phone | +1 905 527 4322 ext. 44490 |
|---|---|
| bhandam@mcmaster.ca |
Study information
| Study design | Single blind (study participant, outcome assessor, data analyst, adjudication committee), randomised trial using minimisation |
|---|---|
| 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 | Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH): a multi-centre randomised trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures |
| Study acronym | FAITH |
| Study objectives | We hypothesise that sliding hip screws will have lower rates of revision surgery (primary outcome) and higher functional outcome scores (secondary outcome) compared with cancellous screws. |
| Ethics approval(s) | Ethics approval received from the Research Ethics Board of McMaster University on the 23rd November 2006 (ref: 06-402). |
| Health condition(s) or problem(s) studied | Femoral neck fractures |
| Intervention | Sliding hip screw fixation versus multiple cancellous screw fixation. |
| Intervention type | Other |
| Primary outcome measure | Revisions surgery as measured at 12 months. |
| Secondary outcome measures | 1. Health related quality of life (12-item short form health survey [SF-12]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months 2. Functional outcomes (Western Ontario and McMaster Osteoarthritis Index [WOMAC]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months 3. Health outcomes (European quality of life instrument [EQ-5D]), measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months 4. Complications, including mortality, avascular necrosis, non-union, implant breakage or failure, and infection (i.e., superficial and deep). Measured post-operatively at 1 week, 2 weeks, 3 months, 6 months, 9 months and 12 months. |
| Overall study start date | 01/06/2008 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 1108 |
| Key inclusion criteria | 1. Adult men or women aged 50 years and older (with no upper age limit) 2. Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI) 3. Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced 4. Operative treatment of displaced fractures within two days (i.e., 48 hours) of presenting to the emergency room 5. Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room 6. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker 7. Anticipated medical optimalisation for operative fixation of the hip 8. Provision of informed consent by patient or legal guardian 9. No other major trauma 10. Low energy fracture (defined as a fall from standing height) |
| Key exclusion criteria | 1. Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture) 2. Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture) 3. Retained hardware around the affected hip 4. Infection around the hip (i.e., soft tissue or bone) 5. Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia) 6. Moderate or severe cognitively impaired patients (i.e., Mini-Mental State Examination (MMSE) Six Item Screener with 3 or more errors) 7. Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation 8. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
McMaster University
Hamilton, Ontario
L8L 8E7
Canada
L8L 8E7
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Website | http://www.mcmaster.ca/ |
|---|---|
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87771)
No information available
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? |
|---|---|---|---|---|---|
| Other publications | design and rationale | 26/06/2014 | 21/10/2019 | Yes | No |
| Results article | preplanned secondary analysis results | 16/10/2019 | 21/10/2019 | Yes | No |
| Results article | results | 01/04/2017 | 21/10/2019 | Yes | No |
Editorial Notes
21/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
3. The NCT number has been added.
