Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- American Orhopaedic Foot and Ankle Score (AOFAS) Score
研究概览
简要总结
This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.
详细描述
Although it has traditionally been accepted that posterior malleolar fractures involving less than 25 percent of the tibial plafond do not require operative fixation, this belief is now questioned. A number of studies have shown that the posterior malleolus contributes significantly to ankle stability. Many studies have also demonstrated that postoperative outcomes are better in patients who underwent posterior malleolar reduction and fixation.
The aim of this prospective study is to show how internal fixation of the posterior malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups will be randomized. The clinical and functional results of 40 patients who will be operated between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years). According to our hypothesis, internally fixed posterior malleolar fractures give better clinical and functional scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Patients who were operated for ankle fractures, including posterior malleolar fracture between 10-25% of the joint surface. Two to five years of follow-up with functional and radiological outcome.
排除标准
- •Posterior malleolar fractures accompanied by severe soft tissue damage after high-energy injury will not be included in the study. Written consent will be obtained from all participants, patients who do not give consent or refuse to participate will not be included in the study. Patients who left the study voluntarily will not be included in the statistics. Patients with additional joint disorders, previous surgery or previous history of ankle complaint will not be included.
结局指标
主要结局
American Orhopaedic Foot and Ankle Score (AOFAS) Score
时间窗: 5 year
Functional outcome score between 0 and 100. Higher score indicates better function.
Short Musculoskeletal Function Assessment (SMFA) Questionnaire
时间窗: 2 year
Functional outcome score between 0 and 100. Higher score indicates a worse function.
Kellgren-Lawrence grading system for osteoarthritis
时间窗: 2 year
Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.
次要结局
未报告次要终点
研究者
Bedri Karaismailoglu
Assistant Professor
Istanbul University - Cerrahpasa (IUC)
