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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25524122
Enrollment
80
Registered
2008-06-13
Start date
2008-06-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral neck fractures Injury, Occupational Diseases, Poisoning Fracture of femur

Interventions

Sliding hip screw fixation versus multiple cancellous screw fixation.

Sponsors

McMaster University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Revisions surgery as measured at 12 months.

Secondary

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026