Broken Ankle Clinical Trial
Official title:
Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
| NCT number | NCT02736370 |
| Other study ID # | 2016-081 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2016 |
| Est. completion date | February 2019 |
| Verified date | September 2023 |
| Source | Spectrum Health Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | February 2019 |
| Est. primary completion date | February 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Men and women ages of 18 and up - Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures - Orthopaedic Trauma Association (OTA) classification of 44A and 44B - English speaking - Able and willing to consent Exclusion Criteria: - Open fractures - OTA classification of 43 and 44C - Patients with diabetes mellitus - No other lower extremity injuries that would affect functional outcomes - Previous use of walking aides - Patients with paralysis or hemiplegia - Ankle fractures requiring syndesmotic repair - Ankle fractures requiring fixation of the posterior malleolar - Associated neurovascular injury - Problems maintaining follow up (homeless or not willing to return for follow up) - Pathological fractures - Prisoners - Patients not allowed to bear weight before the 6 week post-operative follow up visit |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Spectrum Health Hospitals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Functional Outcome Scores | During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes. | 12 months post operatively | |
| Secondary | Return to work | During follow up visits the patients return to work status will be assessed. | up to 12 months | |
| Secondary | Fracture Healing | During follow up visits fractures healing will be assessed by physician review of x-rays. | up to 12 months | |
| Secondary | Pain Scores | Pain Scores and PROMIS Pain Intensity and Interference questionnaires will be assessed during follow up. These forms will be analyzed together to determine the patients overall pain. | 12 months post operatively | |
| Secondary | Post operative complications | Post operative complications will be assessed during follow up visits. | up to 12 months |