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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
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The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Compression | Active Comparator | Nail will be seated using conventional compression technique |
|
| Standard Backslapping | Active Comparator | Nail will be seated using standard backslapping technique |
|
| Dynamic Locking with Backslapping | Active Comparator | Nail will be seated using backslapping with dynamic locking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Compression | Device | Method of Nail fitting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of Tibia Fracture by Radiographic Exam | Healing of Tibia Fracture by radiographic exam | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Sagi | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
Currently there is no plan
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Compression | Nail will be seated using conventional compression technique Conventional Compression: Method of Nail fitting |
| FG001 | Standard Backslapping | Nail will be seated using standard backslapping technique Standard Backslapping: Method of Nail fitting |
| FG002 | Dynamic Locking With Backslapping | Nail will be seated using backslapping with dynamic locking Dynamic Locking with Backslapping: Method of Nail fitting |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Compression | Nail will be seated using conventional compression technique Conventional Compression: Method of Nail fitting |
| BG001 | Standard Backslapping | Nail will be seated using standard backslapping technique Standard Backslapping: Method of Nail fitting |
| 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 | Healing of Tibia Fracture by Radiographic Exam | Healing of Tibia Fracture by radiographic exam | MD left institution project closed data not collected | Posted | One Year |
|
up to 52 weeks
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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 | Conventional Compression | Nail will be seated using conventional compression technique Conventional Compression: Method of Nail fitting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| julie agel | harborview medical center | 206.744.4113 | bagel@uw.edu |
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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 | Sep 5, 2023 | May 2, 2024 | Prot_SAP_000.pdf |
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Participant Blinding
| Standard Backslapping |
| Device |
Method of Nail fitting |
|
| Dynamic Locking with Backslapping | Device | Method of Nail fitting |
|
| BG002 | Dynamic Locking With Backslapping | Nail will be seated using backslapping with dynamic locking Dynamic Locking with Backslapping: Method of Nail fitting |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Nail will be seated using backslapping with dynamic locking Dynamic Locking with Backslapping: Method of Nail fitting |
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Standard Backslapping | Nail will be seated using standard backslapping technique Standard Backslapping: Method of Nail fitting | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Dynamic Locking With Backslapping | Nail will be seated using backslapping with dynamic locking Dynamic Locking with Backslapping: Method of Nail fitting | 0 | 1 | 0 | 1 | 0 | 1 |
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