Ankle Fracture Clinical Trial
Official title:
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
NCT number | NCT02779244 |
Other study ID # | 16-00720 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | July 1, 2023 |
Verified date | November 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | July 1, 2023 |
Est. primary completion date | June 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Operative unstable ankle fractures Exclusion Criteria: - Requirement of syndesmotic fixation - Pilon fractures - Open fractures - Patients with diabetic neuropathy - BMI>40 - Polytrauma patients - Patients who are unable to comply with non-weight bearing - Patients who are unable to follow up |
Country | Name | City | State |
---|---|---|---|
United States | New York University Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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