Arthroscopic Partial Meniscectomy Versus Physical Therapy for Patients Over 45 Years With a Meniscal Tears: 5-year Follow-up of the ESCAPE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 主要终点
- Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
研究概览
简要总结
Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.
With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear
排除标准
- •Knee locking or trauma leading to acute surgery;
- •▸ Associated injuries on the index knee consisting of:
- •Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
- •Posterior cruciate ligament tear,
- •OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,
- •An injury to the lateral or posterolateral ligament complex with significant laxity;
- •Previous knee surgery on the index knee (with the exception of diagnostic arthroscopy);
- •Tumour that is suspected of malignancy, detectable on MRI;
- •Obesity with a body mass index >35;
- •American Society of Anesthesiologists (ASA) class 4 or 5 patients;
- •General disease that effects physical function or systemic medication/abuse of steroids;
- •Any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to MRI or surgery;
- •Drugs or alcohol abuse;
- •Patients unable to fill out the Dutch questionnaires.
结局指标
主要结局
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
时间窗: 60 months
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire to assess patient reported knee functionWe assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.
次要结局
- Radiographic Knee osteoarthritis(60 months)
- Symptomatic knee osteoarthritis (OA)(60 months)
- Patient reported knee pain during weight bearing(60 months)
- Patient reported quality of life(60 months)
研究者
Rudolf W Poolman, MD PhD
Principal Investigator
Onze Lieve Vrouwe Gasthuis