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

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761813
• Other study ID #: R01AR055267
• Secondary ID: R01AR055267
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: January 3, 2018
• Start date: March 2009
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00557167

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1108
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mission Hospital Res. Unit	Asheville	North Carolina
United States	University of Alabama @ Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Univ. of Cincinnati Med Ctr	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Miami Valley Hospital	Dayton	Ohio
United States	Mark Hammerberg	Denver	Colorado
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	Rocky Mountain Orthopaedic/Western Slope Study Group	Grand Junction	Colorado
United States	Orthopaedic Associates of Grand Rapids	Grand Rapids	Michigan
United States	Greenville Hospital System	Greenville	South Carolina
United States	Indiana University-Wishard Hlth Serv.	Indianapolis	Indiana
United States	OrthoIndy	Indianapolis	Indiana
United States	Kamran Aurang, MD	Irvine	California
United States	Texas Tech Univ. Hlth Sci. Ctr.	Lubbock	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Orthopaedic Instititute	Nashville	Tennessee
United States	Robert Wood Johnson University	New Brunswick	New Jersey
United States	University of Califnornia-Irvine	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester Med. Ctr.	Rochester	New York
United States	Colleen Linehan, MD	Saginaw	Michigan
United States	St. Louis University	Saint Louis	Missouri
United States	University of Minnesota-Regions Hospital	Saint Paul	Minnesota
United States	University of Texas HSC (San Antonio)	San Antonio	Texas
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Northwest Orthopaedic Specialists	Spokane	Washington
United States	Scott & White Hospital	Temple	Texas
United States	Humility of Mary Health Partners/St. Elizabeth Hlth Ctr	Youngstown	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Canadian Institutes of Health Research (CIHR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Stichting Nuts Ohra, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision Surgery	Additional Surgery on the affected hip	Measured 2 years after original surgery
Secondary	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
Secondary	Complications, Including Avascular Necrosis, Nonunion, and Infection		Measured 2 years after original surgery