Contact information
Type
Scientific
Primary contact
Dr Mohit Bhandari
ORCID ID
Contact details
McMaster University
293 Wellington Street North
Suite 110
Hamilton
Ontario
L8L 8E7
Canada
+1 905 527 4322 ext. 44490
bhandam@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-87771
Study information
Scientific title
Acronym
FAITH
Study hypothesis
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
Ethics approval received from the Research Ethics Board of McMaster University on the 23rd November 2006 (ref: 06-402).
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
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
Femoral neck fractures
Intervention
Sliding hip screw fixation versus multiple cancellous screw fixation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/06/2008
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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)
Recruitment start date
01/06/2008
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton, Ontario
L8L 8E7
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87771)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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