Ankle Fractures
Conditions
Brief summary
The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management. Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort. All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.
Interventions
PROCEDUREankle open reduction internal fixation
Open Reduction and Internal Fixation with plates and screws
closed reduction and splinting followed by progressive weight bearing
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years old * able to provide informed consent
Exclusion criteria
* pregnancy * prisoners * psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up * insulin dependent diabetics * patients with prior musculoskeletal issues affecting the same extremity * Patients cannot simultaneously be enrolled in any other studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiographic outcome of ankle congruency | 1 year | measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system | 1 year | total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points) |
| additional functional outcome by Short Form Survey (SF-36) Score scoring system | 1 year | 0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5 |
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score | 1 year | none, mild occasional, moderate daily, severe and almost always present |
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements | 1 year | no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities |
| functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment | 1 year | good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment |
Outcome results
None listed