| ID | Type | Description | Link |
|---|---|---|---|
| R01AR055267 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Stichting Nuts Ohra | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Sliding Hip Screw | Experimental |
| |
| Multiple Cancellous Screws | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open reduction internal fixation (ORIF) with single sliding hip screw | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Revision Surgery | Additional Surgery on the affected hip | Measured 2 years after original surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Swiontkowski, MD | University of Minnesota | Principal Investigator |
| Mohit Bhandari, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama @ Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Kamran Aurang, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35767811 | Derived | 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. | |
| 28262269 |
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Subjects were consented and then randomized. Some subjects were enrolled but dropped prior to randomization. Or withdrew after being randomized so no data was collected
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Sliding Hip Screw | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| The Physicians' Services Incorporated Foundation |
| OTHER |
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|
| ORIF with multiple cancellous screws | 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. |
|
| Complications, Including Avascular Necrosis, Nonunion, and Infection |
| Measured 2 years after original surgery |
| Irvine |
| California |
| 92618 |
| United States |
| University of Califnornia-Irvine | Orange | California | 92868 | United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| Mark Hammerberg | Denver | Colorado | 80204 | United States |
| Rocky Mountain Orthopaedic/Western Slope Study Group | Grand Junction | Colorado | 81505 | United States |
| Indiana University-Wishard Hlth Serv. | Indianapolis | Indiana | 46202 | United States |
| OrthoIndy | Indianapolis | Indiana | 46202 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Orthopaedic Associates of Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Colleen Linehan, MD | Saginaw | Michigan | 48602 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55441 | United States |
| University of Minnesota-Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Columbia Orthopaedic Group | Columbia | Missouri | 65201 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Robert Wood Johnson University | New Brunswick | New Jersey | 08901 | United States |
| University of Rochester Med. Ctr. | Rochester | New York | 14642 | United States |
| Mission Hospital Res. Unit | Asheville | North Carolina | 28801 | United States |
| Univ. of Cincinnati Med Ctr | Cincinnati | Ohio | 45267 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Humility of Mary Health Partners/St. Elizabeth Hlth Ctr | Youngstown | Ohio | 44501 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Vanderbilt University Orthopaedic Instititute | Nashville | Tennessee | 37232 | United States |
| US Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234 | United States |
| Texas Tech Univ. Hlth Sci. Ctr. | Lubbock | Texas | 79430 | United States |
| University of Texas HSC (San Antonio) | San Antonio | Texas | 78229-3900 | United States |
| Scott & White Hospital | Temple | Texas | 76508 | United States |
| Northwest Orthopaedic Specialists | Spokane | Washington | 99216 | United States |
| 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. |
| 24965132 | Derived | 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. |
| 22225733 | Derived | 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. |
| FG001 | Multiple Cancellous Screws | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Sliding Hip Screw | 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. |
| BG001 | Multiple Cancellous Screws | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Revision Surgery | Additional Surgery on the affected hip | Posted | Count of Participants | Participants | 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 | secondary outcomes not given or completed to all subjects | Posted | Mean | Standard Deviation | units on a scale | Measured 2 years after original surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Complications, Including Avascular Necrosis, Nonunion, and Infection | Posted | Number | participants | Measured 2 years after original surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Sliding Hip Screw | 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. | 2 | 542 | 115 | 542 | 55 | 542 |
| EG001 | Multiple Cancellous Screws | 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. | 8 | 537 | 104 | 537 | 45 | 537 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Blood Complications | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| Altered mental Status | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cancer | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiovascular | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Death | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Digestive Events | Gastrointestinal disorders | CTCAE (4.0) |
| ||
| Fall | General disorders | CTCAE | Systematic Assessment |
| |
| Hernia | General disorders | CTCAE | Systematic Assessment |
| |
| Infection/Sepsis | Infections and infestations | CTCAE | Systematic Assessment |
| |
| Other | General disorders | CTCAE | Systematic Assessment |
| |
| Other fractures | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal Disease/Events | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| UTI | Renal and urinary disorders | CTCAE (4.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Avascular Necrosis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cancer | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiovascular Event | Cardiac disorders | Medra | Systematic Assessment |
| |
| Deep Brain Thrombosis | General disorders | Medra | Systematic Assessment |
| |
| Infection | Infections and infestations | Medra | Systematic Assessment |
| |
| Metal Allergy | General disorders | Medra | Systematic Assessment |
| |
| Other | General disorders | Medra | Systematic Assessment |
| |
| Pnuemonia | Respiratory, thoracic and mediastinal disorders | Medra | Systematic Assessment |
| |
| Prolonged Hospitalization | General disorders | Medra | Systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Medra | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | Medra | Systematic Assessment |
| |
| Sepsis | General disorders | Medra | Systematic Assessment |
|
Surgeons and patients were not blinded.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Minnesota | 612.273.8000 | swion001@umn.edu |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| Male |
|
| Canada |
|
| United Kingdom |
|
| Netherlands |
|
| Norway |
|
| Germany |
|
| India |
|
| Australia |
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| Units | Counts |
|---|---|
| Participants |
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