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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Device: Open reduction internal fixation (ORIF) with single sliding hip screw; Device: ORIF with multiple cancellous screws

Detailed Description

One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part of the femur bone where the head of the femur is joined to the main shaft. The break can be either undisplaced, which involves very little separation at the fracture site, or displaced, in which there is substantial separation. Surgeons agree that the best surgical procedure for an undisplaced fracture is internal fixation, in which a mechanical implant reconnects the two separated segments of bone. For displaced fractures, surgeons usually choose between internal fixation and a hip joint replacement.

There is more than one way to perform internal fixation. The majority of orthopaedic surgeons currently favor the use of multiple small diameter cancellous screws. However, an alternative method that uses a single large diameter screw attached to a sideplate, called a sliding hip screw, has been gaining popularity and might reduce post-surgical complications and the need for revision surgery. Which surgical method is best for the patient is unknown. This study will compare the use of multiple small diameter cancellous screws versus a single sliding hip screw on rates of revision surgery 2 years after patients sustain femoral neck fractures and undergo internal fixation. The study will also compare the impact of the two different surgical procedures on the overall health, function, and quality of life of patients. Results from this study may impact current orthopaedic practice.

Participation in this study will last 2 years. Before surgery, participants will complete a baseline assessment that will include x-rays, a medical history review, and a physical examination. Participants will then be randomly assigned to undergo one of two types of internal fixation surgeries for repairing their hip fractures. In one group of participants, surgeons will use at least two small cancellous threaded screws that have a diameter of at least 6.5 mm. In the other group of participants, surgeons will use a single large diameter screw that is partially threaded. This screw, called a sliding hip screw, will be affixed to the femur bone with a sideplate, and there will be no other fixations. All surgeons, who will need to meet certain criteria to partake in the study, will follow the manufacturers' technique guidelines for using either type of screw. Specific aspects of both the pre-operative and post-operative care, such as the use of antibiotics and calcium supplementation, will be standardized for all participants.

Follow-up assessments will be completed either by phone or in-person at the hospital or clinic. They will occur 1, 2, and 10 weeks after surgery and 6, 9, 12, 18, and 24 months after surgery. All assessments will include questionnaires and interviews on health status, hip function, pain, and revision surgery. Some of the in-person assessments will also include x-rays.

• Study Type: Interventional
• Enrollment (Actual): 1108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama @ Birmingham
  • California
    • Irvine, California, United States, 92618
      • Kamran Aurang, MD
    • Orange, California, United States, 92868
      • University of Califnornia-Irvine
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
  • Colorado
    • Denver, Colorado, United States, 80204
      • Mark Hammerberg
    • Grand Junction, Colorado, United States, 81505
      • Rocky Mountain Orthopaedic/Western Slope Study Group
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • OrthoIndy
    • Indianapolis, Indiana, United States, 46202
      • Indiana University-Wishard Hlth Serv.
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Orthopaedic Associates of Grand Rapids
    • Saginaw, Michigan, United States, 48602
      • Colleen Linehan, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55441
      • Hennepin County Medical Center
    • Saint Paul, Minnesota, United States, 55101
      • University of Minnesota-Regions Hospital
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopaedic Group
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Med. Ctr.
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital Res. Unit
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Univ. of Cincinnati Med Ctr
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital
    • Youngstown, Ohio, United States, 44501
      • Humility of Mary Health Partners/St. Elizabeth Hlth Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Orthopaedic Instititute
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • US Army Institute of Surgical Research
    • Lubbock, Texas, United States, 79430
      • Texas Tech Univ. Hlth Sci. Ctr.
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas HSC (San Antonio)
    • Temple, Texas, United States, 76508
      • Scott & White Hospital
  • Washington
    • Spokane, Washington, United States, 99216
      • Northwest Orthopaedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Sliding Hip Screw	Device: 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.
Experimental: Multiple Cancellous Screws	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision Surgery	Additional Surgery on the affected hip	Measured 2 years after original surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The SF-12 PCS is the short form - 12 Health Survey Physical component summary - 0 is bad and 100 is good The WOMAC is Western Ontario and McMaster Universities Osteoarthritis Index 0 is good and 100 is bad The EQ-5D is EuroQol5D 1 is good and 5 is bad	Measured 2 years after original surgery
Complications, Including Avascular Necrosis, Nonunion, and Infection		Measured 2 years after original surgery

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Canadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated Foundation; Stichting Nuts Ohra
• Investigators: Principal Investigator: Marc Swiontkowski, MD, University of Minnesota

Publications and helpful links

General Publications

• 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 Jun 21;480(12):2350-60. doi: 10.1097/CORR.0000000000002283. Online ahead of print.
• Fixation 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.
• FAITH 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.
• Zielinski 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Sliding Hip Screw Fixation; Cannulated Screw Fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: R01AR055267 (U.S. NIH Grant/Contract)