NCT05706363进行中（未招募）不适用
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Kujala (Anterior Knee Pain Scale)
研究概览
简要总结
The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.
It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
- •The growth zones must be found closed - verified by MRI scan
排除标准
- •Patients with known rheumatoid arthritis.
- •Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
- •Inability to follow a normal rehabilitation regime.
- •Previous ligament surgery in injured knees.
结局指标
主要结局
Kujala (Anterior Knee Pain Scale)
时间窗: 24 month
Patient reported outcome score, 0=worst and 100=best
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS)(24 month)
- Donor site morbidity score, 0=worst and 100=best(24 month)
- Lysholm-Tegner (Activity Score)(24 month)
- Numerical Rating Scale (NRS-pain score)(24 month)
- Knee pain(24 month)
- Patella Re-luxation sensation(24 month)
研究者
Martin Lind
Professor
Aarhus University Hospital
研究点 (2)
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