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Extremely low enrollment and very little follow-up for meaningful data
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The purpose of this study is to evaluate patients with tibial plateau fractures.
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.
Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior pin placement | Experimental | Anterior pin placement |
|
| Lateral pin placement | Experimental | Lateral pin placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior pin placement | Device | Anteriorly-placed (front of the leg) femoral external fixator pins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Strength | measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose | (admission, 6 weeks, 3 months, 6 months) 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Crist, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Anterior | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins |
| FG001 | 2 Lateral | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
initially based on power analysis for anticipated quad strength data, final numbers based on those completing study in each group
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-anterior Pin Placement | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins |
| BG001 | 2-lateral Pin Placement | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind |
| 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 |
| 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 | Quadriceps Strength | measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose | Posted | Mean | Standard Deviation | Nm | (admission, 6 weeks, 3 months, 6 months) 1 year |
|
1 year
14 patients completed the study
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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 | 1 Anterior | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett D. Crist, MD | University of Missouri | 5738826562 | cristb@health.missouri.edu |
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| ID | Term |
|---|---|
| D005596 | Fractures, Closed |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| Lateral pin placement | Device | Laterally-placed (side of the leg) femoral external fixator pind |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| 2 |
| 5 |
| 0 |
| 5 |
| EG001 | 2 Lateral | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind | 3 | 9 | 0 | 9 |
| infection | Infections and infestations | Non-systematic Assessment | knee infection |
|
| arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | knee arthrofibrosis |
|
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