Cost-effectiveness of Early Surgery Versus Conservative Treatment With Optional Delayed Meniscectomy in Older Patients. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 16
- 主要终点
- International Knee Documentation Committee 'Subjective Knee Form'
研究概览
简要总结
The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.
The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.
详细描述
Rationale: Arthroscopic Partial Meniscectomy (APM) is the most performed orthopaedic procedure and is current standard treatment for patients with meniscal tears. Since superiority of APM over conservative treatment has not well been described and studies with direct comparison between APM and conservative treatment are sparse, therefore there is risk of large healthcare inefficiency.
Study design: Non-inferiority multicenter randomized controlled trial with an economic evaluation alongside. The study will be conducted by the Orthopaedic Research Consortium Mid-West Netherlands and performed in 6 clinics, including 2 academic medical centers.
402 patients between 45 and 70 years with Magnetic Resonance Imaging (MRI)-confirmed symptomatic, non-obstructive meniscal tears will be included. Patients will be assigned to either APM (n=201) or Physical Therapy (PT; n=201), with optional delayed APM (cross-over) when conservative treatment has failed. Block randomization will be done stratified for age and site. Data will be analysed on both intention to treat and per protocol basis.
Measurement points:
- Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18, 24 and 60 months.
- At both 3 and 24 months they will visit the outpatient department for physical examination.
- At 24 and 60 months an X-ray will be obtained.
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
- •Patients between 45 and 70 years of age at presentation.
- •A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic Anterior Cruciate Ligament (ACL) injury or an asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift).
- •Mental Competence.
- •Willingness to comply with follow up schedule.
- •Written informed consent.
排除标准
- •Knee locking or trauma leading to acute surgery.
- •One of the following associated injuries on the index knee:
- •A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI;
- •A complete Posterior Cruciate Ligament (PCL) injury;
- •Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
- •An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
- •A history of knee surgery other than diagnostic arthroscopy on the index knee.
- •Tumors on MRI suspected for a malignancy.
- •Obese patients with Body Mass Index (BMI) >
- •ASA 4-5 patients which can severely interfere with rehabilitation.
- •General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
- •Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery.
- •Drugs or alcohol abuse.
- •Patients unable to speak or read Dutch.
结局指标
主要结局
International Knee Documentation Committee 'Subjective Knee Form'
时间窗: 3, 6, 12, 24 and 60 months
Primary outcome will be change in physical function from baseline to 2 years measured by the International Knee Documentation Committee (IKDC) 'Subjective Knee Form', which has been validated for meniscal injuries. In addition, 1) the investigators will perform an economic analysis alongside the Randomized Controlled Trial (RCT) from a societal perspective and a budget impact analysis from societal, government and insurer perspective. 2\) The primary outcome after 5 years will be investigated
次要结局
- RAND-36 Physical Functional Status Scale(3, 6, 12 and 24 months)
- EQ-5D-5L Quality of life measure(3, 6, 9, 12, 18, 24 and 60 months)
- Tegner Activity Scale(3, 6, 12 and 24 months)
- VAS pain score(3, 6, 12, 24 and 60 months)
- Health Care Utilization and productivity losses(3, 6, 9, 12, 18 and 24 months)
- Knee Osteoarthritis Outcome Score-Physical functioning Short from (KOOS-PS)(60 months)
- Patient Specific Complaints questionnaire(3, 6 ,12 and 24 months)
- Physical Examination(3 and 24 months)
研究者
Victor van de Graaf
MD
Onze Lieve Vrouwe Gasthuis