Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Kellgren-Lawrence (K/L) grade change
研究概览
简要总结
The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)
详细描述
Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Clinical diagnosis of degenerative meniscus lesions based on knee MRI
排除标准
- •• Must be able to have no acute knee injury such as car crash or acute sports injury;
- •Must be able to have no knee surgeries history;
- •Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- •Must be able to have no contraindications to MRI;
- •Must be able to have no severe cardiopulmonary disease;
- •Must be able to have no musculoskeletal or neuromuscular impairments ;
- •Must be able to have good visual, hearing, or cognitive;
结局指标
主要结局
Kellgren-Lawrence (K/L) grade change
时间窗: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade via X ray
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change
时间窗: change from baseline up to 12 months
Te WOMAC is a self assessed health status scale for patients consisting of 24 items in three subscales of pain (5 items), stiffness (2 items), and physical function (17 items). All items are scored from 0 (asymptomatic) to 4 (very severe), and the total score ranges from 0 to 96, with higher scores indicating more severe symptoms
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
时间窗: change from baseline up to 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
时间窗: change from baseline up to 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
次要结局
- KOOS pain score change(change from baseline up to 12 months)
- KOOS symptoms score change(change from baseline up to 12 months)
- KOOS activities of daily living score change(change from baseline up to 12 months)
- KOOS function in sport and recreation score change(change from baseline up to 12 months)
- KOOS knee related quality of life score change(change from baseline up to 12 months)