Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
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| ClinicalTrials.gov Identifier: NCT00761813 |
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Recruitment Status :
Completed
First Posted : September 30, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Femoral Neck Fractures | Device: Open reduction internal fixation (ORIF) with single sliding hip screw Device: ORIF with multiple cancellous screws | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 1108 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | March 2009 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
| 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. |
- Revision Surgery [ Time Frame: Measured 2 years after original surgery ]Additional Surgery on the affected hip
- Quality of Life [ Time Frame: Measured 2 years after original surgery ]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
- Complications, Including Avascular Necrosis, Nonunion, and Infection [ Time Frame: Measured 2 years after original surgery ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761813
Show 32 study locations
| Principal Investigator: | Marc Swiontkowski, MD | University of Minnesota | |
| Principal Investigator: | Mohit Bhandari, MD | McMaster University |
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00761813 |
| Obsolete Identifiers: | NCT00557167 |
| Other Study ID Numbers: |
R01AR055267 ( U.S. NIH Grant/Contract ) R01AR055267 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 30, 2008 Key Record Dates |
| Results First Posted: | January 5, 2018 |
| Last Update Posted: | January 5, 2018 |
| Last Verified: | January 2018 |
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Sliding Hip Screw Fixation Cannulated Screw Fixation |
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Fractures, Bone Hip Fractures Femoral Neck Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |