Analysis of Prognosis and Risk Factors of Lateral Ankle Ligament Reconstruction Procedure for Patients With Avulsion Fracture of the Lateral Ankle Ligament: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Karlsson score
研究概览
简要总结
To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome.
详细描述
80 patients with external ankle ligament injury without avulsion fracture and 40 patients with external ankle ligament injury combined with avulsion fracture were treated by surgery in our department. The outcomes included Karlsson score, VAS, AOFAS and Tegner score. The outcomes were compared between the two groups, and the risk factors were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old
- •Chronic pain or instability in the ankle, injury to the lateral collateral ligament of the ankle determined by MRI examination of the ankle, and distal avulsion fracture of the fibula indicated by CT examination.
- •Patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs
- •Patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up
排除标准
- •Persons who have participated in clinical trials of other drugs or medical devices within the last 6 months
- •Malalignment of ankle joint force (varus or valgus >5 degrees)
- •Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
- •Patients with joint fibrosis, joint stiffness, and obvious limited movemente. Moderate to severe osteoarthritis (Takakura stage III or IV)
- •f. Patients with contraindications to MRI g. Hemophiliacs h. Patients with systemic conditions that cannot tolerate surgery
结局指标
主要结局
Karlsson score
时间窗: 2 weeks, 3 months, 6 months, 1 year, and 2 years
The Karlsson score consists of seven questions covering ankle pain, swelling, levels of daily activity and exercise .et al,provided by the patient with objective scores. The minimum and maximum values of Karlsson are 0 and 100, respectively. And higher scores mean a better outcome
次要结局
- Tegner Scale(2 weeks, 3 months, 6 months, 1 year, and 2 years)
- Visual Analogue Scale (VAS)(2 weeks, 3 months, 6 months, 1 year, and 2 years)
- American Orthopaedic Foot and Ankle Society (AOFAS)(2 weeks, 3 months, 6 months, 1 year, and 2 years)