Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrent patellar dislocation (percentage of patients)
研究概览
简要总结
Study to evaluate the conservative treatment of patients after their first episode of primary lateral patellar dislocation. Randomized controlled trial with 2 groups: standard treatment (2-weeks with brace) followed by physical therapy, compared with knee taping and physical therapy. 1-year follow-up. Measurements include physical exam, radiographs and MRI. Outcomes: recurrence, lateral patellar tilt, functional scores, apprehension, pain.
Hypothesis: less recurrence in the knee taping group, as well as better functional scores.
详细描述
Patients between 10-40 years old with first patellar dislocation are invited to participate in this conservative treatment study.
Patients are excluded if they have bilateral acute patellar dislocation, previous surgeries in the affected knee, osteochondral fracture, open patellar dislocation.
This is a randomized controlled trial with four groups of treatment:
- Standard treatment (2-weeks with a knee brace) and physical therapy
- Knee taping and physical therapy (1-week with knee brace)
Sample size: 50 patients / knees Outcomes of interest: recurrence in patellar dislocation, functional scores (Banff, Norwich), return to sport, patellar tilt
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and outcomes assessor will not have access to the type of treatment a patient received.
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with first episode of acute lateral patellar dislocation during the last 7 days.
排除标准
- •* Patients with acute bilateral patellar dislocation.
- •Patients with open patellar dislocation.
- •Patients with previous knee surgery in the same knee.
结局指标
主要结局
Recurrent patellar dislocation (percentage of patients)
时间窗: 2 years
Percentage of patients with additional patellar dislocation after the first episode
次要结局
- Nich patellar instability (NPI) score(2 years)
- Banff Patellofemoral Instability Instrument (BPII)(2 years)