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Clinical Trials/CTRI/2011/09/001986
CTRI/2011/09/001986
Completed
Phase 4

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

McMaster University0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Hip FracturesFemoral Neck Fractures
Sponsor
McMaster University
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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