Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
Fixation Using Alternative Implants for the Treatment of Hip Fractures: A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures
1 other identifier
interventional
1,108
1 country
32
Brief Summary
Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with this injury are expected to soon reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a femoral neck fracture, is often treated with a surgical procedure called internal fixation. When performing internal fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a single large diameter screw with a sliding plate. However, use of the sliding hip screw might in fact result in fewer complications after surgery and reduce the need for a second surgery, called a revision surgery. This study will compare the two different surgical procedures to determine which one results in better outcomes after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
January 5, 2018
CompletedJanuary 5, 2018
January 1, 2018
7 years
September 26, 2008
November 2, 2017
January 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Revision Surgery
Additional Surgery on the affected hip
Measured 2 years after original surgery
Secondary Outcomes (2)
Quality of Life
Measured 2 years after original surgery
Complications, Including Avascular Necrosis, Nonunion, and Infection
Measured 2 years after original surgery
Study Arms (2)
Single Sliding Hip Screw
EXPERIMENTALMultiple Cancellous Screws
EXPERIMENTALInterventions
The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
Eligibility Criteria
You may qualify if:
- Fracture of femoral neck
- Operative treatment within 4 days for displaced fractures
- Operative treatment within 7 days for nondisplaced fractures
- Ambulatory before the injury
- Low energy trauma, such as falls from a sitting or standing position
- No other major trauma
You may not qualify if:
- Unsuited for both surgical treatments
- Associated major injuries of the lower extremities
- Retained hardware around the hip
- Infection around the hip
- Bone metabolic disorder (except for osteoporosis)
- Moderate or severe cognitive impairment
- Parkinson's disease or dementia
- Unable to complete the 2-year follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
University of Alabama @ Birmingham
Birmingham, Alabama, 35294, United States
Kamran Aurang, MD
Irvine, California, 92618, United States
University of Califnornia-Irvine
Orange, California, 92868, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Mark Hammerberg
Denver, Colorado, 80204, United States
Rocky Mountain Orthopaedic/Western Slope Study Group
Grand Junction, Colorado, 81505, United States
Indiana University-Wishard Hlth Serv.
Indianapolis, Indiana, 46202, United States
OrthoIndy
Indianapolis, Indiana, 46202, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Orthopaedic Associates of Grand Rapids
Grand Rapids, Michigan, 49503, United States
Colleen Linehan, MD
Saginaw, Michigan, 48602, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55441, United States
University of Minnesota-Regions Hospital
Saint Paul, Minnesota, 55101, United States
Columbia Orthopaedic Group
Columbia, Missouri, 65201, United States
St. Louis University
St Louis, Missouri, 63110, United States
Robert Wood Johnson University
New Brunswick, New Jersey, 08901, United States
University of Rochester Med. Ctr.
Rochester, New York, 14642, United States
Mission Hospital Res. Unit
Asheville, North Carolina, 28801, United States
Univ. of Cincinnati Med Ctr
Cincinnati, Ohio, 45267, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Humility of Mary Health Partners/St. Elizabeth Hlth Ctr
Youngstown, Ohio, 44501, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Vanderbilt University Orthopaedic Instititute
Nashville, Tennessee, 37232, United States
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Texas Tech Univ. Hlth Sci. Ctr.
Lubbock, Texas, 79430, United States
University of Texas HSC (San Antonio)
San Antonio, Texas, 78229-3900, United States
Scott & White Hospital
Temple, Texas, 76508, United States
Northwest Orthopaedic Specialists
Spokane, Washington, 99216, United States
Related Publications (4)
van de Kuit A, Oosterhoff JHF, Dijkstra H, Sprague S, Bzovsky S, Bhandari M, Swiontkowski M, Schemitsch EH, IJpma FFA, Poolman RW, Doornberg JN, Hendrickx LAM; , the Machine Learning Consortium and FAITH Investigators. Patients With Femoral Neck Fractures Are at Risk for Conversion to Arthroplasty After Internal Fixation: A Machine-learning Algorithm. Clin Orthop Relat Res. 2022 Dec 1;480(12):2350-2360. doi: 10.1097/CORR.0000000000002283. Epub 2022 Jun 21.
PMID: 35767811DERIVEDFixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial. Lancet. 2017 Apr 15;389(10078):1519-1527. doi: 10.1016/S0140-6736(17)30066-1. Epub 2017 Mar 3.
PMID: 28262269DERIVEDFAITH Investigators. Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures. BMC Musculoskelet Disord. 2014 Jun 26;15:219. doi: 10.1186/1471-2474-15-219.
PMID: 24965132DERIVEDZielinski SM, Viveiros H, Heetveld MJ, Swiontkowski MF, Bhandari M, Patka P, Van Lieshout EM; FAITH trial investigators. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience. Trials. 2012 Jan 8;13:5. doi: 10.1186/1745-6215-13-5.
PMID: 22225733DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Surgeons and patients were not blinded.
Results Point of Contact
- Title
- Principal Investigator
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Swiontkowski, MD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Mohit Bhandari, MD
McMaster University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
March 1, 2009
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 5, 2018
Results First Posted
January 5, 2018
Record last verified: 2018-01