Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- radiographic outcome of ankle congruency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years old
- •able to provide informed consent
排除标准
- •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.
研究组 & 干预措施
non operative control group
Patients with negative gravity stress (non-operative treatment/observational control group)
干预措施: non operative management (Other)
non operative experimental group
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.
干预措施: non operative management (Other)
operative observational group
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
干预措施: ankle open reduction internal fixation (Procedure)
结局指标
主要结局
radiographic outcome of ankle congruency
时间窗: 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
次要结局
- functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system(1 year)
- additional functional outcome by Short Form Survey (SF-36) Score scoring system(1 year)
- functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score(1 year)
- functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements(1 year)
- functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment(1 year)
研究者
Charles Moon
Principal Investigator
Cedars-Sinai Medical Center