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Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)

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ClinicalTrials.gov Identifier: NCT00761813
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Canadian Institutes of Health Research (CIHR)
Stichting Nuts Ohra
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Femoral Neck Fractures
Interventions: Device: Open reduction internal fixation (ORIF) with single sliding hip screw
Device: ORIF with multiple cancellous screws

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were consented and then randomized. Some subjects were enrolled but dropped prior to randomization. Or withdrew after being randomized so no data was collected

Reporting Groups
  Description
Single Sliding Hip Screw Open reduction internal fixation (ORIF) with single sliding hip screw: 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.
Multiple Cancellous Screws ORIF with multiple cancellous screws: 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.

Participant Flow:   Overall Study
    Single Sliding Hip Screw   Multiple Cancellous Screws
STARTED   557   551 
COMPLETED   542   537 
NOT COMPLETED   15   14 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Sliding Hip Screw Open reduction internal fixation (ORIF) with single sliding hip screw: 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.
Multiple Cancellous Screws ORIF with multiple cancellous screws: 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.
Total Total of all reporting groups

Baseline Measures
   Single Sliding Hip Screw   Multiple Cancellous Screws   Total 
Overall Participants Analyzed 
[Units: Participants]
 542   537   1079 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.2  (12.0)   72.0  (12.3)   72.1  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   330   327   657 
Male   212   210   422 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   211   209   420 
Canada   111   109   220 
United Kingdom   7   9   16 
Netherlands   121   126   247 
Norway   11   12   23 
Germany   2   2   4 
India   62   63   125 
Australia   24   24   48 


  Outcome Measures

1.  Primary:   Revision Surgery   [ Time Frame: Measured 2 years after original surgery ]

2.  Secondary:   Quality of Life   [ Time Frame: Measured 2 years after original surgery ]

3.  Secondary:   Complications, Including Avascular Necrosis, Nonunion, and Infection   [ Time Frame: Measured 2 years after original surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Surgeons and patients were not blinded.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: University of Minnesota
phone: 612.273.8000
e-mail: swion001@umn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00761813     History of Changes
Obsolete Identifiers: NCT00557167
Other Study ID Numbers: R01AR055267 ( U.S. NIH Grant/Contract )
R01AR055267 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: November 2, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018