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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Open Reduction and Internal Fixation with plates and screws
closed reduction and splinting followed by progressive weight bearing
radiographic outcome of ankle congruency
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
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points)
Time frame: 1 year
additional functional outcome by Short Form Survey (SF-36) Score scoring system
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
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
none, mild occasional, moderate daily, severe and almost always present
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
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
Time frame: 1 year
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment
Time frame: 1 year
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