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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Femoral Neck Fractures

In brief

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.

Key facts

Study ID

NCT01908751

Run by

McMaster University

People needed

91

Starts

2014-09-01

Expected to finish

2019-03-18

Last updated by the study team

2020-11-30

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Patient has an allergy to vitamin D or another contraindication to being prescribed vitamin D.
• Patient is currently taking an over counter drug and/or food supplement that contains vitamin D and is unable or unwilling to discontinue its use for this study.
• Likely problems, in the judgment of the attending surgeon, with maintaining follow up (e.g. patients with no fixed address, plans to move out of town). This may include patients with severe mental disorders and drug addictions without adequate support.
• Pregnancy.
• Patient is incarcerated.
• Patient is not expected to survive injuries.
• The attending surgeon believes the patient should be excluded because they are involved in a conflicting clinical trial.

Where it is running

• The Center for Orthopedic Research and Education (CORE) Institute — Phoenix, Arizona, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Indiana University (IU Health Methodist Hospital) — Indianapolis, Indiana, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Hennepin Healthcare System — Minneapolis, Minnesota, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Inova Health Care Services — Falls Church, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States
• Alfred Health — Melbourne, Victoria, Australia
• Royal Columbian Hospital — New Westminster, British Columbia, Canada
• University of British Columbia & Vancouver Costal Health Authority — Vancouver, British Columbia, Canada
• Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
• Memorial University — St. John's, Newfoundland and Labrador, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• Sunnybrook Research Institute — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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