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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AORIF of Ankle Fractures | Experimental | Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture. |
|
| ORIF of Ankle Fractures | Active Comparator | Open Reduction Internal Fixation of ankle fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Assisted Open Reduction Internal Fixation | Procedure | Surgical fixation of ankle fractures with use of arthroscopy. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Anderson, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
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| Open Reduction Internal Fixation | Procedure | Surgical fixation of ankle fractures. |
|
|
| 1 year |
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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