Clinical trial NCT00761813: Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Sliding Hip Screw Fixation
Cannulated Screw Fixation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Canadian Institutes of Health Research (CIHR)
name: Stichting Nuts Ohra
name: The Physicians' Services Incorporated Foundation
First posted: 2008-09-30
Enrollment: 1108
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Revision Surgery
timeFrame: Measured 2 years after original surgery
Secondary outcomes:
measure: Quality of Life
timeFrame: Measured 2 years after original surgery
measure: Complications, Including Avascular Necrosis, Nonunion, and Infection
timeFrame: Measured 2 years after original surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama @ Birmingham
state: Alabama
city: Irvine
country: United States
facility: Kamran Aurang, MD
state: California
city: Orange
country: United States
facility: University of Califnornia-Irvine
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Denver
country: United States
facility: Mark Hammerberg
state: Colorado
city: Grand Junction
country: United States
facility: Rocky Mountain Orthopaedic/Western Slope Study Group
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University-Wishard Hlth Serv.
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Grand Rapids
state: Michigan
city: Saginaw
country: United States
facility: Colleen Linehan, MD
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Paul
country: United States
facility: University of Minnesota-Regions Hospital
state: Minnesota
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson University
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Med. Ctr.
state: New York
city: Asheville
country: United States
facility: Mission Hospital Res. Unit
state: North Carolina
city: Cincinnati
country: United States
facility: Univ. of Cincinnati Med Ctr
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Youngstown
country: United States
facility: Humility of Mary Health Partners/St. Elizabeth Hlth Ctr
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Orthopaedic Instititute
state: Tennessee
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
city: Lubbock
country: United States
facility: Texas Tech Univ. Hlth Sci. Ctr.
state: Texas
city: San Antonio
country: United States
facility: University of Texas HSC (San Antonio)
state: Texas
city: Temple
country: United States
facility: Scott & White Hospital
state: Texas
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists
state: Washington
Study officials:
affiliation: University of Minnesota
name: Marc Swiontkowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Mohit Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.