Is Deltoid Ligament Repair for Ankle Fracture Necessary?

Study Overview
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Brief Summary
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The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.

Detailed Description
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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.

Official Title
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Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.

Conditions
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Ankle Fracture

Intervention / Treatment
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* Procedure: Repair Deltoid Tendon
* Other: Ankle Fracture Without Deltoid Tendon Repair


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Supination-external rotation ankle fracture with deltoid ligament incompetency Minimum of 2 year clinical follow up Exclusion criteria: Non-supination-external rotation ankle fracture Medial malleolus fracture Incomplete clinical or radiographic followup.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deltoid Tendon Repaired<br>Repair Deltoid Tendon | Procedure: Repair Deltoid Tendon<br> <br> |
| Other: Ankle Fracture Without Deltoid Tendon Repair<br> | Other: Ankle Fracture Without Deltoid Tendon Repair<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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.) | 2 year postoperative visit |