Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures
NCT ID: NCT03084263
Last Updated: 2017-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-05-01
2019-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AORIF of Ankle Fractures
Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.
Arthroscopic Assisted Open Reduction Internal Fixation
Surgical fixation of ankle fractures with use of arthroscopy.
ORIF of Ankle Fractures
Open Reduction Internal Fixation of ankle fracture.
Open Reduction Internal Fixation
Surgical fixation of ankle fractures.
Interventions
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Arthroscopic Assisted Open Reduction Internal Fixation
Surgical fixation of ankle fractures with use of arthroscopy.
Open Reduction Internal Fixation
Surgical fixation of ankle fractures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages of 18-65
* Men or women, including pregnant women
* Willing to consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Spectrum Health Hospitals
OTHER
Responsible Party
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Principal Investigators
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Kevin Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
Spectrum Health Hospitals
Locations
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Spectrum Health
Grand Rapids, Michigan, United States
Countries
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Other Identifiers
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2017-061
Identifier Type: -
Identifier Source: org_study_id
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