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

NCT01908751 | Terminated Phase 3 Results DMC

• 1 other identifier: FAITH-2
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 20

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 outcomes.

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Patient Important Outcomes

  A participant met the primary clinical endpoint if they experienced one or more of the four outcomes: 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.

  12 months post-surgery

Secondary Outcomes (6)

• Number of Participants With Non-Operatively-Treated Fracture Healing Complications

  12 months post-surgery

• Short Form-12 (SF-12) Physical Composite Scale (PCS)

  Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

• Short Form-12 (SF-12) Mental Health Composite Scale (MCS)

  Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

• Hip Outcome Score (HOS) Activities of Daily Living Scale

  Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

• Hip Outcome Score (HOS) Sports Scale

  Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

Study Arms (4)

Sliding Hip Screw and Vitamin D supplementation

EXPERIMENTAL

Participants allocated to the vitamin D Group will be given a six-month supply of vitamin D3 supplementation. Participants in 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; Drug: Vitamin D

Sliding Hip Screw and Vitamin D placebo

EXPERIMENTAL

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; Drug: Vitamin D Placebo

Cancellous Screws and Vitamin D supplementation

EXPERIMENTAL

Participants allocated to the vitamin D Group will be given a six-month supply of vitamin D3 supplementation. Participants in 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; Drug: Vitamin D

Cancellous Screws and Vitamin D placebo

EXPERIMENTAL

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; Drug: Vitamin D Placebo

Interventions

Sliding Hip Screw PROCEDURE

Sliding Hip Screw and Vitamin D placebo; Sliding Hip Screw and Vitamin D supplementation

Cancellous Screws PROCEDURE

Cancellous Screws and Vitamin D placebo; Cancellous Screws and Vitamin D supplementation

Vitamin D DRUG

Cancellous Screws and Vitamin D supplementation; Sliding Hip Screw and Vitamin D supplementation

Vitamin D Placebo DRUG

Cancellous Screws and Vitamin D placebo; Sliding Hip Screw and Vitamin D placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McMaster Surgical Associates: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (20)

The Center for Orthopedic Research and Education (CORE) Institute

Phoenix, Arizona, 85023, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Indiana University (IU Health Methodist Hospital)

Indianapolis, Indiana, 46202, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hennepin Healthcare System

Minneapolis, Minnesota, 55415, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

University of British Columbia & Vancouver Costal Health Authority

Vancouver, British Columbia, Canada

Location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Memorial University

St. John's, Newfoundland and Labrador, A1B 3X9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (21)

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  PMID: 10546628 BACKGROUND

• Bee CR, Sheerin DV, Wuest TK, Fitzpatrick DC. Serum vitamin D levels in orthopaedic trauma patients living in the northwestern United States. J Orthop Trauma. 2013 May;27(5):e103-6. doi: 10.1097/BOT.0b013e31825cf8fb.

  PMID: 22576645 BACKGROUND

• Bhandari M, Devereaux PJ, Swiontkowski MF, Tornetta P 3rd, Obremskey W, Koval KJ, Nork S, Sprague S, Schemitsch EH, Guyatt GH. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003 Sep;85(9):1673-81. doi: 10.2106/00004623-200309000-00004.

  PMID: 12954824 BACKGROUND

• Bhandari M, Tornetta P 3rd, Hanson B, Swiontkowski MF. Optimal internal fixation for femoral neck fractures: multiple screws or sliding hip screws? J Orthop Trauma. 2009 Jul;23(6):403-7. doi: 10.1097/BOT.0b013e318176191f.

  PMID: 19550225 BACKGROUND

• Chen Z, Wang G, Lin J, Yang T, Fang Y, Liu L, Zhang H. [Efficacy comparison between dynamic hip screw combined with anti-rotation screw and cannulated screw in treating femoral neck fractures]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Jan;25(1):26-9. Chinese.

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• Damany DS, Parker MJ, Chojnowski A. Complications after intracapsular hip fractures in young adults. A meta-analysis of 18 published studies involving 564 fractures. Injury. 2005 Jan;36(1):131-41. doi: 10.1016/j.injury.2004.05.023.

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  PMID: 15386160 BACKGROUND

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  PMID: 19807897 BACKGROUND

• Johansson A, Stromqvist B, Bauer G, Hansson LI, Pettersson H. Improved operations for femoral neck fracture. A radiographic evaluation. Acta Orthop Scand. 1986 Dec;57(6):505-9. doi: 10.3109/17453678609014779.

  PMID: 3577716 BACKGROUND

• Langlois K, Greene-Finestone L, Little J, Hidiroglou N, Whiting S. Vitamin D status of Canadians as measured in the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2010 Mar;21(1):47-55.

  PMID: 20426226 BACKGROUND

• Lappe J, Cullen D, Haynatzki G, Recker R, Ahlf R, Thompson K. Calcium and vitamin d supplementation decreases incidence of stress fractures in female navy recruits. J Bone Miner Res. 2008 May;23(5):741-9. doi: 10.1359/jbmr.080102.

  PMID: 18433305 BACKGROUND

• Lidor C, Dekel S, Hallel T, Edelstein S. Levels of active metabolites of vitamin D3 in the callus of fracture repair in chicks. J Bone Joint Surg Br. 1987 Jan;69(1):132-6. doi: 10.1302/0301-620X.69B1.3029136.

  PMID: 3029136 BACKGROUND

• Linde F, Andersen E, Hvass I, Madsen F, Pallesen R. Avascular femoral head necrosis following fracture fixation. Injury. 1986 May;17(3):159-63. doi: 10.1016/0020-1383(86)90322-0.

  PMID: 3818052 BACKGROUND

• Lindequist S. Cortical screw support in femoral neck fractures. A radiographic analysis of 87 fractures with a new mensuration technique. Acta Orthop Scand. 1993 Jun;64(3):289-93. doi: 10.3109/17453679308993627.

  PMID: 8322583 BACKGROUND

• Malchau H, Herberts P, Eisler T, Garellick G, Soderman P. The Swedish Total Hip Replacement Register. J Bone Joint Surg Am. 2002;84-A Suppl 2:2-20. doi: 10.2106/00004623-200200002-00002. No abstract available.

  PMID: 12479335 BACKGROUND

• Omeroglu H, Ates Y, Akkus O, Korkusuz F, Bicimoglu A, Akkas N. Biomechanical analysis of the effects of single high-dose vitamin D3 on fracture healing in a healthy rabbit model. Arch Orthop Trauma Surg. 1997;116(5):271-4. doi: 10.1007/BF00390051.

  PMID: 9177802 BACKGROUND

• Omeroglu S, Erdogan D, Omeroglu H. Effects of single high-dose vitamin D3 on fracture healing. An ultrastructural study in healthy guinea pigs. Arch Orthop Trauma Surg. 1997;116(1-2):37-40.

  PMID: 9006763 BACKGROUND

• Patil S, Garbuz DS, Greidanus NV, Masri BA, Duncan CP. Quality of life outcomes in revision vs primary total hip arthroplasty: a prospective cohort study. J Arthroplasty. 2008 Jun;23(4):550-3. doi: 10.1016/j.arth.2007.04.035. Epub 2007 Oct 23.

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• Sakalli H, Arslan D, Yucel AE. The effect of oral and parenteral vitamin D supplementation in the elderly: a prospective, double-blinded, randomized, placebo-controlled study. Rheumatol Int. 2012 Aug;32(8):2279-83. doi: 10.1007/s00296-011-1943-6. Epub 2011 May 10.

  PMID: 21556746 BACKGROUND

• Swiontkowski MF, Harrington RM, Keller TS, Van Patten PK. Torsion and bending analysis of internal fixation techniques for femoral neck fractures: the role of implant design and bone density. J Orthop Res. 1987;5(3):433-44. doi: 10.1002/jor.1100050316.

  PMID: 3625366 BACKGROUND

• FAITH-2 Investigators; Slobogean GP, Sprague S, Bzovsky S, Heels-Ansdell D, Thabane L, Scott T, Bhandari M. Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 x 2 factorial randomized controlled trial in young femoral neck fracture patients. Pilot Feasibility Stud. 2019 May 28;5:70. doi: 10.1186/s40814-019-0458-x. eCollection 2019.

  PMID: 31161044 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Mohit Bhandari
• Organization: McMaster University

bhandam@mcmaster.ca

9055274322

Study Officials

• Gerard Slobogean, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Mohit Bhandari, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Sheila Sprague, PhD

  McMaster University (Role: Research Methodologist)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2014
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: November 30, 2020
• Results First Posted: November 30, 2020

Record last verified: 2020-11

Locations

AU (1); CA (9); US (10)