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This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM Nails | Other | Reamed, Interlocking Intramedullary Nail - Randomized treatment |
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| Plate Fixation | Other | Locking Periarticular Plate - Randomized Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reamed, interlocking intramedullary nail | Device | Standard of care device for femur fracture repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best. | 3 months, 6 months, 12 months |
| Short Musculoskeletal Functional Assessment (SMFA) Score | The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function. | 3 months, 6 months, 12 months |
| EQ Index | EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best. | 3 months, 6 months, 12 months |
| SMFA - Bother Index | The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury. | 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Valgus of Over 5 Degrees | Valgus is a deformity involving oblique displacement of part of a limb away from the midline. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Tornetta, M.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Davis | Sacramento | California | 95817 | United States | ||
| Tampa General Hospital |
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Although 160 participants were enrolled into the study, only 156 were included in the participant flow because 2 were found ineligible after consent and 2 withdrew before fixation.
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| ID | Title | Description |
|---|---|---|
| FG000 | IM Nails | Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair |
| FG001 | Plate Fixation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| locking periarticular plate | Device | Standard of care device for femur fractures |
|
| Tampa |
| Florida |
| 33606 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| UMass Memorial Medical Center | Worchester | Massachusetts | 01605 | United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| Orthopaedic Associates of Michigan | Grand Rapids | Michigan | 49525 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| St. Mary's Hospital - Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Barnes Hospital | St Louis | Missouri | 63110 | United States |
| St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| New York Hospital for Joint Diseases | New York | New York | 10003 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma/ Health Science | Oklahoma City | Oklahoma | 73190 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Campbell Foundation | Memphis | Tennessee | 38104 | United States |
| Orthopaedic Specialty Associates Fort Worth | Fort Worth | Texas | 76104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures
| COMPLETED |
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| NOT COMPLETED |
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156 Patients were randomized to locked plate (80) or IM nail (76). Data for only 126 participants were captured due to patient withdrawal or incomplete data from sites
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| ID | Title | Description |
|---|---|---|
| BG000 | IM Nails | Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair |
| BG001 | Plate Fixation | Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | EQ-5D | EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best. | 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months, 12 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Short Musculoskeletal Functional Assessment (SMFA) Score | The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function. | 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered were followed. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months, 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | EQ Index | EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best. | 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months, 12 months |
|
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| Primary | SMFA - Bother Index | The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury. | 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months, 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Valgus of Over 5 Degrees | Valgus is a deformity involving oblique displacement of part of a limb away from the midline. | 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed. | Posted | Number | participants | 12 months |
|
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2 weeks, 6 weeks, 3 months, 6 months, 12 months
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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 | IM Nails | Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair | 3 | 76 | 16 | 76 | ||
| EG001 | Plate Fixation | Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures | 4 | 80 | 14 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject expired due to cancer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Subject expired due to cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Subject expired due to unknown reason | Cardiac disorders | Non-systematic Assessment | no information provided |
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| Nonunion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Painful Implant | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pulmonary Embolism | Cardiac disorders | Non-systematic Assessment |
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| Construct loosening | Surgical and medical procedures | Non-systematic Assessment |
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| Deep Vein Thrombosis | Surgical and medical procedures | Non-systematic Assessment |
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| Infection | Surgical and medical procedures | Non-systematic Assessment |
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| Fractured Implant | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hardware Irritation | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Contralateral TKA | Surgical and medical procedures | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Tornetta III, MD | Boston Medical Center | 617-414-6295 | paul.tornetta@bmc.org |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| >=65 years |
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| Male |
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| 12 months |
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