Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale
研究概览
简要总结
The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.
详细描述
There are no studies proving a significant positive effect of a knee arthroscopy in middleaged patients with meniscal symptoms in excess of a structured rehabilitation program. In this study consecutive patients aged 45-64 years referred to the orthopaedic department at the University hospital Linköping for a suspected meniscal injury will be randomised to a rehabilitation program or a knee arthroscopy + the same rehabilitation program. Functional tests will be performed by a physiotherapist. There will be patient administrated questionaries sent out after 3 and 12 month.
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 (Investigator)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All (consecutive) patients referred to the orthopaedic department in Linköping for a suspected meniscal injury
- •Age:45-64 years old
- •No gonarthrosis (Ahlbäck=0) on standing radiographs
排除标准
- •Rheumatic disease
- •Patellofemoral arthrosis
- •Fibromyalgia
- •A knee or hip replacement
- •A neurologic disorder including stroke
- •A contraindication for an operation
- •Catching or locking for more than 2 seconds more than once a week
- •A permanent extension deficit
- •Patients who cannot understand instructions in Swedish
结局指标
主要结局
KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale
时间窗: 12 month
KOOS is a 42 item selfadministrated questionnaire with 5 separate subscales; pain, symptoms, activities of daily living (ADL), sport and recreation, quality of life (QoL). A change of approximately 10 is considered a clinical important difference (CID). At 12 month after the randomization the "arthroscopy+exercise therapy" arm will be compared to the "exercise therapy alone" arm.
次要结局
- KOOS (Knee injury and Osteoarthritis Outcome Score)(3 month)
- Tegner activity scale(12 month)
- KOOS (Symptoms, ADL, Sport/rec, QOL subscores)(12 month)
- Functional tests(3 month)
研究者
Hakan Gauffin
MD PhD
University Hospital, Linkoeping