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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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 multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia 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 |
|---|---|---|---|
| Randomized Treatment - Nail | Other | Randomized Treatment - Nail |
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| Randomized Treatment - Plate | Other | Randomized Treatment - Plate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reamed, interlocking intramedullary nail | Device | Standard of care device for tibia fracture repair; Randomized Treatment - Nail |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Quality of Life at 3 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | 3 months |
| Participants' Quality of Life at 6 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | 6 months |
| Participants' Quality of Life at 12 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems. | 12 months |
| Injury Related Limitations and Concerns at 3 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fracture Nonunions | A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays. | 12 months |
| Number of Participants With Superficial Infections |
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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 Alabama - Burmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California at Davis |
9 participants were enrolled but were not randomized. Of those 9, 6 were found ineligible after consent and 3 withdrew consent prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Treatment - Nail | Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail |
| FG001 | Randomized Treatment - Plate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2017 |
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| locking periarticular plate | Device | Standard of care device for tibia fracture repair; Randomized Treatment - Plate |
|
| 3 months |
| Injury Related Limitations and Concerns at 6 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. | 6 months |
| Injury Related Limitations and Concerns at 12 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother. | 12 month follow-up |
A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.
| 6 months |
| Number of Participants With Deep Infections | A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | 6 months |
| Number of Participants With Compartment Syndrome | Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | 6 months |
| Number of Participants With Malunion (>5 Degrees Varus/Valgus) | Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays. | 12 months |
| Davis |
| California |
| 95616 |
| United States |
| University of California-San Francisco | San Francisco | California | 94143 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| IU Health Methodist Hospital | 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 | Worcester | 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 |
| Duke University Medical Center | Durham | North Carolina | 27710 | 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 science university | Portland | Oregon | 97239 | United States |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| Campbell Foundation | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Orthopaedic Specialty Associates - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| St. Michaels Hospital - Toronto | Toronto | Ontario | M5C 1R6 | Canada |
Randomized Treatment - Plate
locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Treatment - Nail | Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail |
| BG001 | Randomized Treatment - Plate | Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Participants' Quality of Life at 3 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | Participants' Quality of Life at 6 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Primary | Participants' Quality of Life at 12 Months | The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Primary | Injury Related Limitations and Concerns at 3 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | Injury Related Limitations and Concerns at 6 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| ||||||||||||||||||||||||||||||
| Primary | Injury Related Limitations and Concerns at 12 Months | Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother. | Posted | Mean | Standard Deviation | score on a scale | 12 month follow-up |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Fracture Nonunions | A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Superficial Infections | A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Deep Infections | A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Compartment Syndrome | Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Malunion (>5 Degrees Varus/Valgus) | Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays. | Posted | Count of Participants | Participants | 12 months |
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6 years
Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
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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 | Randomized Treatment - Nail | Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail | 1 | 52 | 4 | 52 | 16 | 52 |
| EG001 | Randomized Treatment - Plate | Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate | 0 | 47 | 2 | 47 | 13 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient fall | Surgical and medical procedures | Systematic Assessment | Patient fell post op day 1 with catastrophic failure of proximal fixation requiring revision surgery |
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| Fracture | Surgical and medical procedures | Systematic Assessment | Extraarticular pilon fracture at distal end of nail requiring orif; Non displaced Dist.Fibula Fx |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Over 1 yr since study enrollment. Patient has osteoporosis contralateral distal femur fracture after low energy fall. |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | ASPIRATION PNEUMONIA |
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| Death | Cardiac disorders | Systematic Assessment | Multitrauma/Stroke/Intracranial Hypertension |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Painful Implant | Surgical and medical procedures | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Nonunion | Surgical and medical procedures | Systematic Assessment |
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| Malunion | Surgical and medical procedures | Systematic Assessment |
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| Wound Breakdown Right Proximal Tibia Surgical Site | Surgical and medical procedures | Systematic Assessment |
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| Anterior compartment not functional | Surgical and medical procedures | Systematic Assessment |
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| Delayed Union | Surgical and medical procedures | Systematic Assessment | delayed fracture healing |
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| Peripheral Nerve Injury | Surgical and medical procedures | Systematic Assessment |
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| DVT | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Tornetta, MD | Boston Medical Center | 617-414-6295 | paul.tornetta@bmc.org |
| Sep 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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