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| ID | Type | Description | Link |
|---|---|---|---|
| T35HL007473 | U.S. NIH Grant/Contract | View source |
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Not able to enroll enough patients for analysis
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.
The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elbow Flexion Cast | Experimental | This cohort will be placed in a long arm flexion cast. |
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| Elbow Extension Cast | Experimental | This cohort will be placed in a long arm extension cast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cast | Other | Application of fiberglass long arm cast. |
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| Measure | Description | Time Frame |
|---|---|---|
| Alignment/Loss of Reduction | During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort. | This will be accessed in clinic via x-rays until 8 weeks status post cast application. |
| Measure | Description | Time Frame |
|---|---|---|
| Cast Complications | We will compare the casting complications between elbow extension versus elbow flexion casting cohorts. Casting complications we will observe will be cast saw burns, cast slipping, and need for bivalve of casts. | Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D011885 | Radius Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| C119975 | POLR1G protein, human |
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Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.
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Casting is an external treatment that cannot be masked from investigators or participants.
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