Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
- Conditions
- Ankle Fractures
- Interventions
- Procedure: ankle open reduction internal fixationOther: non operative management
- Registration Number
- NCT03625154
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 18-65 years old
- able to provide informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description operative observational group ankle open reduction internal fixation Patients with positive gravity stress (medial clear space \> 4 mm) who undergo a reduction with closing of the medial clear space to \<4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group non operative experimental group non operative management Patients with positive gravity stress (medial clear space \> 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to \<4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot. non operative control group non operative management Patients with negative gravity stress (non-operative treatment/observational control group)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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