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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
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ISRCTN
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ISRCTN25524122
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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FAITH
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Serial number at source
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MCT-87771
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the Research Ethics Board of McMaster University on the 23rd November 2006 (ref: 06-402).
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Study design
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Single blind (study participant, outcome assessor, data analyst, adjudication committee), randomised trial using minimisation
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Femoral neck fractures
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/06/2008
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Anticipated end date
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01/01/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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Sliding hip screw fixation versus multiple cancellous screw fixation.
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Primary outcome measure(s)
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Revisions surgery as measured at 12 months.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87771)
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Trial website
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http://www.ihfrc.ca
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Publications
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Contact name
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Dr
Mohit
Bhandari
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Address
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McMaster University
293 Wellington Street North
Suite 110
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City/town
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Hamilton, Ontario
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Zip/Postcode
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L8L 8E7
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Country
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Canada
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Tel
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+1 905 527 4322 ext. 44490
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Fax
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+1 905 523 8781
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Email
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bhandam@mcmaster.ca
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Sponsor
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McMaster University (Canada)
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Address
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1200 Main Street West
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City/town
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Hamilton, Ontario
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Zip/Postcode
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L8N 3Z5
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Country
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Canada
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Sponsor website:
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http://www.mcmaster.ca/
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Date applied
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13/06/2008
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Last edited
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13/06/2008
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Date ISRCTN assigned
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13/06/2008
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