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

• Status: Terminated
• Trial end date: 2019-03-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Hamilton Health Sciences Corporation; McMaster Surgical Associates
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria

1. Adult men or women ages 18 to 60 years.

2. Fracture of the femoral neck.

3. Fracture amenable to both surgical treatments (SHS and cancellous screws).

4. Operative treatment within 7 days of injury.

5. Provision of informed consent by patient or substitute decision maker.

Exclusion Criteria

1. Patients with previously diagnosed osteoporosis.

2. Fracture-dislocation of the femoral neck and hip joint.

3. Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present).

4. Current infection around the hip (i.e. soft tissue or bone).

5. Stress fracture of the femoral neck.

6. Pathologic fractures secondary to neoplasm or other bone lesion.

7. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc.

8. Patients with hyperhomocysteinemia.

9. Patient has an allergy to vitamin D or another contraindication to being prescribed vitamin D.

10. 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.

11. 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.

12. Pregnancy.

13. Patient is incarcerated.

14. Patient is not expected to survive injuries.

15. The attending surgeon believes the patient should be excluded because they are involved in a conflicting clinical trial.