Fixation using Alternative Implants for the Treatment of Hip Fractures (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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

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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 2 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 optimalization for operative fixation of the hip by anesthesia and/or internal medicine team.
•8. Provision of informed consent by patient or legal guardian.
•9. Low energy fracture (defined as a fall from standing height).
•10. No other major trauma.

•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 other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy).
•6. Moderate or severe cognitively impaired patients (i.e., 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.

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