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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by McMaster University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Mohit Bhandari, McMaster University
ClinicalTrials.gov Identifier:
NCT01908751
First received: July 18, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Femoral Neck Fractures
Procedure: Sliding Hip Screw
Procedure: Cancellous Screws
Dietary Supplement: Vitamin D
Dietary Supplement: Vitamin D Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): A Multi-Centre 2x2 Factorial Randomized Trial Comparing Sliding Hip Screws Versus Cancellous Screws AND Vitamin D Versus Placebo on Patient Important Outcomes and Quality of Life in the Treatment of Young Adult (18-60) Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • A composite of patient important outcomes [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    1. Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture;
    2. Femoral head osteonecrosis: any evidence of osteonecrosis on any follow-up medical imaging study (i.e., radiographs, magnetic resonance imaging (MRI), or other advanced imaging study);
    3. Severe femoral neck malunion: fracture healing with femoral neck shortening of >10 mm in any plane on follow-up x-rays; or
    4. Nonunion: failure of the fracture to progress towards healing defined as a Radiographic Union Score for Hip (RUSH score below a pre-determined threshold specific for nonunion at 6 months or greater post-injury.


Secondary Outcome Measures:
  • Fracture healing complications [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    E.g. wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, painful hardware, and peri-prosthetic fracture.

  • Short Form-12 (SF-12) [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    The SF-12 is a 12-item questionnaire that measures self-reported quality of life through an 8-domain profile of functional health and well-being, physical and mental health summary measures and a preference-based health utility index.

  • Hip Outcome Score (HOS) [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports.

  • Radiographic fracture healing [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    The date of healing will be determined by the Central Adjudication Committee (CAC). They will consider a fracture as healed when there is obliteration of the fracture line by newly formed bone along the cortices and within the trabecular bone on anterior-posterior and lateral radiographs.


Estimated Enrollment: 898
Study Start Date: September 2014
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sliding Hip Screw and Vitamin D supplementation
Participants will be given a six-month supply of vitamin D3 supplementation or placebo. Participants allocated to the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
Procedure: Sliding Hip Screw Dietary Supplement: Vitamin D
Experimental: Sliding Hip Screw and Vitamin D placebo
Participants in the placebo group will receive an identical bottle of placebo drops with no active ingredient. Similarly, they will be instructed to take two drops daily for six months. The placebo supplement is also manufactured by the Ddrops Company.
Procedure: Sliding Hip Screw Dietary Supplement: Vitamin D Placebo
Experimental: Cancellous Screws and Vitamin D supplementation
Participants will be given a six-month supply of vitamin D3 supplementation or placebo. Participants allocated to the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
Procedure: Cancellous Screws Dietary Supplement: Vitamin D
Experimental: Cancellous Screws and Vitamin D placebo
Participants in the placebo group will receive an identical bottle of placebo drops with no active ingredient. Similarly, they will be instructed to take two drops daily for six months. The placebo supplement is also manufactured by the Ddrops Company.
Procedure: Cancellous Screws Dietary Supplement: Vitamin D Placebo

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 annually. Hip fractures in younger aged patients are particularly devastating with profound impairments of quality of life and function. Virtually all patients require surgical repair of their fractures and unlike elderly hip fractures, failure of surgery offers few options for salvage. Arthroplasty is a successful treatment for elderly patients; however, a hip replacement is not a viable option for younger patients because of their higher functional demands for work and recreational activities that are not tolerated by joint replacements.

There is more than one way to perform internal fixation for femoral neck fractures. Cancellous screws have traditionally been the preferred internal fixation implant for femoral neck fractures. Multiple screws (2 or more) are used during fixation, and advocates of this implant promote the construct's superior torsional stability, limited disruption of femoral head blood supply, minimally invasive insertion, and retention of more viable bone than the larger sliding hip screw (SHS). On the other hand, Sliding hip screws have been gaining popularity and there is evidence to suggest that SHS provide greater fracture stability and may reduce patient complications. It is currently unknown which method of internal fixation provides the best outcomes for patients.

Femoral neck fracture treatment is further complicated by vitamin D insufficiency in as many as 8 of 10 trauma patients. Vitamin D plays an important role in musculoskeletal health and bone quality because it regulates serum calcium homeostasis. Laboratory research and human clinical studies suggest important associations between vitamin D, musculoskeletal health, and improved fracture healing. Experimental animal studies have demonstrated the concentration of vitamin D metabolites are higher at a fracture callus compared to the uninjured contralateral bone, vitamin D supplementation leads to decreased time to fracture union and increased callus vascularity, and vitamin D increases mechanical bone strength compared to controls. Clinical studies have also demonstrated that vitamin D supplementation increases the callus volume of proximal humerus fractures, increases the number and diameter of type II muscle fibres, and can improve wound healing, however, the effects of vitamin D supplementation in you patients with femoral neck fractures are unknown.

Using a 2x2 factorial design, participant will be randomly allocated to one of four treatment arms. Participants allocated to the cancellous screw group will receive multiple threaded screws (with a minimum of 3 screws and a minimum diameter of 6.5 mm) and those allocated to the sliding hip screw group will receive a single larger diameter partially threaded screw affixed to the proximal femur with a sideplate using a minimum of 2 screws for fixation. Participants allocated to the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops. Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. Participants in the placebo group will receive an identical bottle of placebo drops with no active ingredient. Similarly, they will be instructed to take two drops daily for six months. All vitamin D3 supplement and placebo bottles will be labeled in a blinded manner according to Health Canada and Good Manufacturing Practice.

Participation in this study will last 12 months. In-person participant follow-up visits will occur at enrollment (baseline), post-surgery, 6 weeks, 3 months, 6 months, 9 months, and 12 months post-surgery. Data for all outcomes and radiographs will be collected at each follow-up visit.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908751

Contacts
Contact: Taryn Scott 905-527-4322 ext 44696 scottta@mcmaster.ca

Locations
Canada
McMaster University Not yet recruiting
Hamilton, Canada
Contact: Mohit Bhandari, MD         
University of British Columbia Not yet recruiting
Vancouver, Canada
Contact: Gerard Slobogean, MD         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Gerard Slobogean, MD University of British Columbia; McMaster University
Principal Investigator: Mohit Bhandari, MD McMaster University
  More Information

Publications:

Responsible Party: Mohit Bhandari, Study Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT01908751     History of Changes
Other Study ID Numbers: FAITH-2
Study First Received: July 18, 2013
Last Updated: August 14, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014