Status:
TERMINATED
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
Conditions:
Femoral Neck Fractures
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 outcom...
Detailed Description
Femoral neck fractures are a type of hip fracture associated with high complication rates and poor functional outcomes. It is estimated that over 300,000 hip fractures occur in patients under age 50 a...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01908751
Start Date
September 1 2014
End Date
March 18 2019
Last Update
November 30 2020
Active Locations (20)
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1
The Center for Orthopedic Research and Education (CORE) Institute
Phoenix, Arizona, United States, 85023
2
University of California, San Francisco
San Francisco, California, United States, 94110
3
University of Florida
Gainesville, Florida, United States, 32611
4
Indiana University (IU Health Methodist Hospital)
Indianapolis, Indiana, United States, 46202