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?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Spectrum Health Hospitals
- Locations
- 2
- Primary Endpoint
- Rate of Return to Sports
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Rate of Return to Sports
Time Frame: 1 year
Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.
Foot and Ankle Ability Measure (FAAM)
Time Frame: 1 year
Compare FAAM scores between AORIF versus ORIF of ankle fractures.
American Orthopedic Foot and Ankle Score (AOFAS)
Time Frame: 6 month
Compare AOFAS scores between AORIF versus ORIF of ankle fractures.
Secondary Outcomes
- Rates of Complications(1 year)
- Pain Scores(1 year)