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

NCT ID: NCT00761813

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single Sliding Hip Screw

Group Type: EXPERIMENTAL

Open reduction internal fixation (ORIF) with single sliding hip screw

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

ORIF with multiple cancellous screws

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Stichting Nuts Ohra

OTHER

Sponsor Role: collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Swiontkowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Mohit Bhandari, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

University of Alabama @ Birmingham

Birmingham, Alabama, United States

Kamran Aurang, MD

Irvine, California, United States

University of Califnornia-Irvine

Orange, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

Mark Hammerberg

Denver, Colorado, United States

Rocky Mountain Orthopaedic/Western Slope Study Group

Grand Junction, Colorado, United States

Indiana University-Wishard Hlth Serv.

Indianapolis, Indiana, United States

OrthoIndy

Indianapolis, Indiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Orthopaedic Associates of Grand Rapids

Grand Rapids, Michigan, United States

Colleen Linehan, MD

Saginaw, Michigan, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Minnesota-Regions Hospital

Saint Paul, Minnesota, United States

Columbia Orthopaedic Group

Columbia, Missouri, United States

St. Louis University

St Louis, Missouri, United States

Robert Wood Johnson University

New Brunswick, New Jersey, United States

University of Rochester Med. Ctr.

Rochester, New York, United States

Mission Hospital Res. Unit

Asheville, North Carolina, United States

Univ. of Cincinnati Med Ctr

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Humility of Mary Health Partners/St. Elizabeth Hlth Ctr

Youngstown, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Greenville Hospital System

Greenville, South Carolina, United States

Vanderbilt University Orthopaedic Instititute

Nashville, Tennessee, United States

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Texas Tech Univ. Hlth Sci. Ctr.

Lubbock, Texas, United States

University of Texas HSC (San Antonio)

San Antonio, Texas, United States

Scott & White Hospital

Temple, Texas, United States

Northwest Orthopaedic Specialists

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35767811 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28262269 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24965132 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22225733 (View on PubMed)

Other Identifiers

R01AR055267

Identifier Type: NIH

Identifier Source: secondary_id

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R01AR055267

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00557167

Identifier Type: -

Identifier Source: nct_alias