Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 14
- 主要终点
- WOMAC Functional Status - Difference From Baseline
研究概览
简要总结
There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type of arthritis that is caused by the breakdown and eventual loss of another type of cartilage that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can easily lead to disability. This study will compare the effectiveness of two recommended treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.
详细描述
OA is the most common form of arthritis in the United States. Symptoms of knee OA include pain in and around the knee that typically worsens with weight-bearing activities, morning stiffness, and tenderness. A person with OA who experiences a torn meniscus--a cartilage structure within the knee that provides stability and proper weight distribution--is especially at risk for disability. Past studies have shown that arthroscopic partial meniscectomy (APM), a type of knee surgery, usually relieves symptoms and improves function in people suffering from a meniscal tear. However, the success of APM is more variable among people with already existing OA. Clinicians are also uncertain about the short- and long-term benefits, drawbacks, and indications for APM in people with OA and meniscal tears. The purpose of this study is to compare the effectiveness of two treatments, APM surgery and standard physical therapy, for people with OA and a torn meniscus.
This study will last 12 years. At the initial study visit, participants will be randomly assigned to one of two groups.
- Group 1 participants will undergo APM surgery at a time that is convenient for the participant and surgeon. After surgery, participants will be referred for rehabilitative physical therapy to regain strength and flexibility of the knee. For participants who choose to do physical therapy, the duration of treatment will depend on individual progress.
- Group 2 participants will receive standard physical therapy to increase strength and flexibility of the knee. This will include one to three weekly exercise sessions over an 8-week period.
The study consists of up to 5 visits to the center:
- Visit 1, the enrollment visit: sign the consent form, fill out a questionnaire, have a physical examination of the knee and find out your treatment group (surgery or physical therapy
- Visit 2, at 3 months after enrollment: Fill out a questionnaire and have a physical examination of the knee
- Visit 3, at 18 months: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees
- Visit 4, at 5 years: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees
- Visit 5, at 12 years: Fill out a questionnaire, have a physical examination of the knee, have an MRI of the knee (if eligible) and xrays of both knees
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA symptoms lasting at least 1 month and managed with medications, activity limitations, and/or physical therapy
- •At least one symptom consistent with a torn meniscus. Symptoms may include clicking, catching, popping, giving way, pain with pivot or torque, episodic pain, and/or pain that is acute and localized to one joint line.
- •Available knee X-ray (within 6 months) and MRI (within 3 years)
- •Evidence of osteophyte formation or cartilage fissure, tear, or loss on a knee MRI OR plain radiographic evidence of osteophyte formation or joint space narrowing
- •Evidence of a meniscal tear (tear extending to surface of meniscus) on a knee MRI
- •Willingness to undergo random assignment and sign an informed consent
排除标准
- •Chronically locked knee
- •Kellgren-Lawrence Grade IV status, indicating advanced OA and usually the need for total knee replacement
- •Contraindication to MRI
- •Radiographic chondrocalcinosis (a condition in which there are deposits of calcium pyrophosphate dihydrate [CPPD] crystals in one or more joints that eventually result in damage to the affected joints) AND acute symptomatic pseudogout
- •Inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
- •Injection with viscosupplementation in the affected knee in the 4 weeks before study entry
- •Any medical contraindications to surgery or physical therapy
- •Both knees are symptomatic for meniscal tears and a candidate for bilateral APMs
- •Prior surgery on an affected knee
- •Pregnancy or possible pregnancy
- •Claim filed for worker's compensation
- •Unable or unwilling to give informed consent
- •Unable or unwilling to attend physical therapy sessions at designated locations or in the community
研究组 & 干预措施
Surgical
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
干预措施: Arthroscopic partial menisectomy (Procedure)
Surgical
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
干预措施: Postoperative rehabilitative physical therapy (Other)
Nonoperative
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
干预措施: Standard physical therapy (Other)
结局指标
主要结局
WOMAC Functional Status - Difference From Baseline
时间窗: Baseline and 6 months
Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.
次要结局
- KOOS Pain - Difference From Baseline(Baseline to 6 months)
- KOOS Pain - Mean at 60 Months(60 months)
- SF-36 Physical Functional Status Scale - Difference From Baseline(6 months)
- Total Knee Replacement - Subjects Received(Baseline to 60 months)
研究者
Jeffrey Neil Katz, MD
Professor of Medicine and Orthopedic Surgery, Harvard Medical School; Director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham & Women's Hospital
Brigham and Women's Hospital