Femoral Neck FracturesNCT00761813
Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
A study testing Open reduction internal fixation (ORIF) with single sliding hip screw and ORIF with multiple cancellous screws in people with Femoral Neck Fractures, run by University of Minnesota at 32 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Open reduction internal fixation (ORIF) with single sliding hip screw and ORIF with multiple cancellous screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,108 participants
- Where
- 32 sitesUnited States
- Study dates
- Mar 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Mission Hospital Res. Unit
Asheville, North Carolina, 28801
University of Alabama @ Birmingham
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
Lahey Clinic
Burlington, Massachusetts, 01805
Univ. of Cincinnati Med Ctr
Cincinnati, Ohio, 45267
MetroHealth Medical Center
Cleveland, Ohio, 44109
Columbia Orthopaedic Group
Columbia, Missouri, 65201
Miami Valley Hospital
Dayton, Ohio, 45409
Mark Hammerberg
Denver, Colorado, 80204
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
Rocky Mountain Orthopaedic/Western Slope Study Group
Grand Junction, Colorado, 81505
Orthopaedic Associates of Grand Rapids
Grand Rapids, Michigan, 49503
Greenville Hospital System
Greenville, South Carolina, 29605
Indiana University-Wishard Hlth Serv.
Indianapolis, Indiana, 46202
OrthoIndy
Indianapolis, Indiana, 46202
Kamran Aurang, MD
Irvine, California, 92618
Texas Tech Univ. Hlth Sci. Ctr.
Lubbock, Texas, 79430
Hennepin County Medical Center
Minneapolis, Minnesota, 55441
Vanderbilt University Orthopaedic Instititute
Nashville, Tennessee, 37232
Robert Wood Johnson University
New Brunswick, New Jersey, 08901
University of Califnornia-Irvine
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester Med. Ctr.
Rochester, New York, 14642
Colleen Linehan, MD
Saginaw, Michigan, 48602
University of Minnesota-Regions Hospital
Saint Paul, Minnesota, 55101
University of Texas HSC (San Antonio)
San Antonio, Texas, 78229-3900
Santa Clara Valley Medical Center
San Jose, California, 95128
Northwest Orthopaedic Specialists
Spokane, Washington, 99216
St. Louis University
St Louis, Missouri, 63110
Scott & White Hospital
Temple, Texas, 76508
Humility of Mary Health Partners/St. Elizabeth Hlth Ctr
Youngstown, Ohio, 44501
About this 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
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.
Read the 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
- Being tested
- Open reduction internal fixation (ORIF) with single sliding hip screw, ORIF with multiple cancellous screws
- Keywords
- Sliding Hip Screw Fixation, Cannulated Screw Fixation
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction internal fixation (ORIF) with single sliding hip screwDevice
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 screwsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Sliding Hip Screw | Experimental | Not described Receives: Device: Open reduction internal fixation (ORIF) with single sliding hip screw |
| Multiple Cancellous Screws | Experimental | Not described Receives: Device: ORIF with multiple cancellous screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision Surgery
Additional Surgery on the affected hip
Measured: Measured 2 years after original surgery
Secondary outcomes (2)
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: Measured 2 years after original surgery
Complications, Including Avascular Necrosis, Nonunion, and Infection
Measured: Measured 2 years after original surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Canadian Institutes of Health Research (CIHR), Stichting Nuts Ohra, The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Marc Swiontkowski, MD, Principal investigator, University of MinnesotaMohit Bhandari, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761813
- Sponsor's protocol ID
- R01AR055267
- Other IDs
- R01AR055267
- Status last verified
- Jan 2018
- First submitted
- 26 Sep 2008
- Last updated
- 5 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 Dec 1;480(12):2350-2360. doi: 10.1097/CORR.0000000000002283. Epub 2022 Jun 21.
PubMed 35767811Fixation 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.
PubMed 28262269FAITH 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.
PubMed 24965132Zielinski 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.
PubMed 22225733
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00761813
- Acronym / sponsor ID
- R01AR055267
- Conditions
- Femoral Neck Fractures
- Keywords
- Sliding Hip Screw Fixation, Cannulated Screw Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,108 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Canadian Institutes of Health Research (CIHR), Stichting Nuts Ohra, The Physicians' Services Incorporated Foundation
- Study start
- Mar 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 5 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Sliding Hip Screw | Experimental | Device: Open reduction internal fixation (ORIF) with single sliding hip screw |
| Multiple Cancellous Screws | Experimental | Device: ORIF with multiple cancellous screws |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction internal fixation (ORIF) with single sliding hip screwThe 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. | Device | Single Sliding Hip Screw |
| ORIF with multiple cancellous screwsORIF 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. | Device | Multiple Cancellous Screws |
Primary outcome
Revision Surgery
Time frame: Measured 2 years after original surgery
Additional Surgery on the affected hip
2 secondary outcomes
Quality of Life
Time frame: Measured 2 years after original surgery
Complications, Including Avascular Necrosis, Nonunion, and Infection
Time frame: Measured 2 years after original surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35767811van 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.
- Derived from this study: PubMed 28262269Fixation 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.
- Derived from this study: PubMed 24965132FAITH 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.
- Derived from this study: PubMed 22225733Zielinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Swiontkowski, MD principal investigator
University of Minnesota
Mohit Bhandari, MD principal investigator
McMaster University
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction internal fixation (ORIF) with single sliding hip screw and ORIF with multiple cancellous screws in people with Femoral Neck Fractures, run by University of Minnesota at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision Surgery (time frame: Measured 2 years after original surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761813, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.