Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures

Study Overview
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Brief Summary
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The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

Detailed Description
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Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF. As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot. In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

Official Title
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A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?

Conditions
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Ankle Fractures

Intervention / Treatment
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* Procedure: Arthroscopic Assisted Open Reduction Internal Fixation
* Procedure: Open Reduction Internal Fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Closed ankle fractures (44A, 44B, 44C) Ages of 18-65 Men or women, including pregnant women Willing to consent Exclusion Criteria: Open fractures Other lower extremity injuries/conditions that affects functional outcomes Problems maintaining follow up (homeless, not willing to return for follow up) Prisoners Unable to consent

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AORIF of Ankle Fractures<br>Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture. | Procedure: Arthroscopic Assisted Open Reduction Internal Fixation<br>* Surgical fixation of ankle fractures with use of arthroscopy.<br>* Other names: AORIF;|
| Active Comparator: ORIF of Ankle Fractures<br>Open Reduction Internal Fixation of ankle fracture. | Procedure: Open Reduction Internal Fixation<br>* Surgical fixation of ankle fractures.<br>* Other names: ORIF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle Score (AOFAS) | Compare AOFAS scores between AORIF versus ORIF of ankle fractures. | 6 month | 
| Foot and Ankle Ability Measure (FAAM) | Compare FAAM scores between AORIF versus ORIF of ankle fractures. | 1 year | 
| Rate of Return to Sports | Compare Return to Sports rates between AORIF versus ORIF of ankle fractures. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Complications | Compare rates of Complication between AORIF versus ORIF of ankle fractures. | 1 year | 
| Pain Scores | Compare Pain Scores between AORIF versus ORIF of ankle fractures. | 1 year |