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PI pulled the study. No participants.
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The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deltoid Tendon Repaired | Experimental | Repair Deltoid Tendon |
|
| Ankle Fracture Without Deltoid Tendon Repair | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repair Deltoid Tendon | Procedure |
| ||
| Ankle Fracture Without Deltoid Tendon Repair |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA) | The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered). The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function. | baseline, 6 month post-operative visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale | The AOFAS Hindfoot Scale is an outcome rating system for ankle replacements. It is composed of the parameters pain (max 40 points), function (max 50 points) and alignment (max 10 points). Scores can range from 0 (severe pain, severely impaired function, and poor alignment) to 100 (no pain, no limitations on function, good alignment.) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn G Shi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| Other |
Standard of care |
|
| 2 year postoperative visit |