TerminatedPhase 3

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)

Stopped: Continuing beyond the pilot phase of the trial was deemed unfeasible

United States91 participantsStarted 2014-09

Plain-language summary

The purpose of this study is to determine the impact of surgical fixation (cancellous screws versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient important outcomes.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Adult men or women ages 18 to 60 years.
✓. Fracture of the femoral neck.
✓. Fracture amenable to both surgical treatments (SHS and cancellous screws).
✓. Operative treatment within 7 days of injury.
✓. Provision of informed consent by patient or substitute decision maker.

Exclusion criteria

✕. Patients with previously diagnosed osteoporosis.
✕. Fracture-dislocation of the femoral neck and hip joint.
✕. Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present).
✕. Current infection around the hip (i.e. soft tissue or bone).
✕. Stress fracture of the femoral neck.
✕. Pathologic fractures secondary to neoplasm or other bone lesion.
✕. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc.
✕. Patients with hyperhomocysteinemia.

What they're measuring

Number of Participants With Patient Important Outcomes

Timeframe: 12 months post-surgery

Trial details

NCT IDNCT01908751

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-18

Results submitted2020-05-15

View on ClinicalTrials.gov More Femoral Neck Fractures trials