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Fixation using Alternative Implants for the Treatment of Hip Fractures

Fixation using Alternative Implants for the Treatment of Hip Fracture (FAITH):A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures - FAITH

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/09/001986
Enrollment
100
Registered
2011-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Hip Fractures Femoral Neck Fractures

Interventions

Intervention1: Multiple cancellous screws fixation: Patients allocated to multiple cancellous screws fixation will receive multiple threaded screws (with a minimum of 2 screws, a minimum diameter of 6

Sponsors

McMaster University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult men or women aged 50 years and older (with no upper age limit). Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced. Operative treatment of displaced fractures within 2 days (i.e., 48 hours) of presenting to the emergency room. Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. Anticipated medical optimalization for operative fixation of the hip. Provision of informed consent by patient or legal guardian. Low energy fracture (defined as a fall from standing height). No other major trauma

Exclusion criteria

Exclusion criteria: Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). 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). Retained hardware around the affected hip. Infection around the hip (i.e., soft tissue or bone). Patients with disorders of bone metabolism except osteoporosis (i.e., Pagets disease, renal osteodystrophy, osteomalacia). Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors). Patients with Parkinsons disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support

Design outcomes

Primary

MeasureTime frame
To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fracturesTimepoint: To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures

Secondary

MeasureTime frame
To determine the impact on health-related quality of life,functional outcomes and health outcomeTimepoint: 2 years

Countries

Australia, Canada, Netherlands, Norway, United States of America

Contacts

Public ContactDr Hrishikesh

iProcess- Scientist

hrishi@iprocess.net

Outcome results

None listed

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