Ankle Fractures
Conditions
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.
Interventions
PROCEDUREArthroscopic Assisted Open Reduction Internal Fixation
Surgical fixation of ankle fractures with use of arthroscopy.
PROCEDUREOpen Reduction Internal Fixation
Surgical fixation of ankle fractures.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopedic Foot and Ankle Score (AOFAS) | 6 month | Compare AOFAS scores between AORIF versus ORIF of ankle fractures. |
| Foot and Ankle Ability Measure (FAAM) | 1 year | Compare FAAM scores between AORIF versus ORIF of ankle fractures. |
| Rate of Return to Sports | 1 year | Compare Return to Sports rates between AORIF versus ORIF of ankle fractures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Complications | 1 year | Compare rates of Complication between AORIF versus ORIF of ankle fractures. |
| Pain Scores | 1 year | Compare Pain Scores between AORIF versus ORIF of ankle fractures. |
Countries
United States
Outcome results
None listed