NCT01908751|TerminatedPhase 3ResultsDMC
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Continuing beyond the pilot phase of the trial was deemed unfeasible
FAITH-2
Sponsor study identifier
interventional
91
3 countries
20
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 18, 2019
Actual (reported)Study Completion
March 18, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2013
Actual (reported)July 26, 2013
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 18, 2019
Actual (reported)March 18, 2019
Actual (reported)November 30, 2020
Actual (reported)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
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
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.
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.
The Center for Orthopedic Research and Education (CORE) Institute
Phoenix, Arizona, 85023, United States
University of California, San Francisco
San Francisco, California, 94110, United States
University of Florida
Gainesville, Florida, 32611, United States
Indiana University (IU Health Methodist Hospital)
Indianapolis, Indiana, 46202, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Hennepin Healthcare System
Baitner AC, Maurer SG, Hickey DG, Jazrawi LM, Kummer FJ, Jamal J, Goldman S, Koval KJ. Vertical shear fractures of the femoral neck. A biomechanical study. Clin Orthop Relat Res. 1999 Oct;(367):300-5.
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.
Gerard Slobogean, MD
University of Maryland, College Park
Mohit Bhandari, MD
McMaster University
Sheila Sprague, PhD
McMaster University (Role: Research Methodologist)
91 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2013
First Posted
July 26, 2013
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Dynaloc for Treatment of Femoral Neck Fractures
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Minneapolis, Minnesota, 55415, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Inova Health Care Services
Falls Church, Virginia, 22042, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Alfred Health
Melbourne, Victoria, 3004, 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, R3A 1R9, Canada
Memorial University
St. John's, Newfoundland and Labrador, A1B 3X9, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
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.
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.
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.
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.
Doetsch AM, Faber J, Lynnerup N, Watjen I, Bliddal H, Danneskiold-Samsoe B. The effect of calcium and vitamin D3 supplementation on the healing of the proximal humerus fracture: a randomized placebo-controlled study. Calcif Tissue Int. 2004 Sep;75(3):183-8. doi: 10.1007/s00223-004-0167-0.
Hamilton B. Vitamin D and human skeletal muscle. Scand J Med Sci Sports. 2010 Apr;20(2):182-90. doi: 10.1111/j.1600-0838.2009.01016.x. Epub 2009 Oct 5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
March 18, 2019
Actual (reported)Study Completion
March 18, 2019
Actual (reported)Last Updated
November 30, 2020
Results First Posted
November 30, 2020
Record last verified: 2020-11
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