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The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Weight Bearing + Cam boot | Experimental |
| |
| Standard Treatment Cam boot | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Weight bearing + Cam Boot | Procedure | Patients will be transitioned to weight bearing as tolerated in a cam boot. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Olerud Molander Ankle Score | The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirmal Tejwan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| Non-Weight Bearing + Cam Boot | Procedure | Subject will be transitioned to non weight bearing cam boot, standard treatment. |
|