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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micromotion Cohort | Experimental | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw |
|
| Standard Cohort | Experimental | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micromotion intramedullary nail cohort | Procedure | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in radiographic union | bridging callus, minimum three cortices bridged | 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| difference in complication rates | Patient reported outcomes scores | 1 year post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Johnson, MD | Contact | 205-934-1041 | jpjohnso@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Johnson, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Main Hospital | Recruiting | Birmingham | Alabama | 35294 | United States |
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Subjects Undergoing Tibial Fracture Repair
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| standard intramedullary nail cohort | Procedure | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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