Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

Study Overview
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Brief Summary
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The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management. Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort. All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.

Official Title
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Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

Conditions
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Ankle Fractures

Intervention / Treatment
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* Procedure: ankle open reduction internal fixation
* Other: non operative management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old able to provide informed consent Exclusion Criteria: pregnancy prisoners psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up insulin dependent diabetics patients with prior musculoskeletal issues affecting the same extremity Patients cannot simultaneously be enrolled in any other studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non operative control group<br>Patients with negative gravity stress (non-operative treatment/observational control group) | Other: non operative management<br>* closed reduction and splinting followed by progressive weight bearing<br>|
| Active Comparator: non operative experimental group<br>Patients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot. | Other: non operative management<br>* closed reduction and splinting followed by progressive weight bearing<br>|
| Active Comparator: operative observational group<br>Patients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group | Procedure: ankle open reduction internal fixation<br>* Open Reduction and Internal Fixation with plates and screws<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic outcome of ankle congruency | measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system | total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points) | 1 year | 
| additional functional outcome by Short Form Survey (SF-36) Score scoring system | 0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5 | 1 year | 
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score | none, mild occasional, moderate daily, severe and almost always present | 1 year | 
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements | no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities | 1 year | 
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment | good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment | 1 year |