Consultant of Shenzhen People's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- SBP
研究概览
简要总结
Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.
详细描述
Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.
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
- •• Must be age between 35 and 70 years old;
- •Clinical diagnosis of metabolic syndrome;
- •Clinical diagnosis of degnerate meniscus tears;
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
SBP
时间窗: at baseline
systolic blood pressure
Knee KOOS score
时间窗: up to 12 month
The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
DBP
时间窗: at baseline
diastolic blood pressure
TC
时间窗: at baseline
serum total cholesterol (TC)
FBG
时间窗: at baseline
serum fast blood glucose(FBG)
IKDC score
时间窗: up to 12 month
The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
waist circumstance
时间窗: at baseline
midway between the lowest rib and the iliac crest, using an anthropometric tape
LDL
时间窗: at baseline
serum low-density lipoprotein cholesterol (LDL-C)
HDL
时间窗: at baseline
serum high-density lipoprotein cholesterol (HDL-C)
TG
时间窗: at baseline
serum triglycerides (TG)
BMI
时间窗: at baseline
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m\^2
K-L grade
时间窗: at baseline
Kellgren-Lawrence (K/L) grade
次要结局
- symptoms score(up to 12 month)
- function in sport and recreation score(up to 12 month)
- activities of daily living score(up to 12 month)
- knee related quality of life score(up to 12 month)
- pain score(up to 12 month)
研究者
Hongyu Wang
chief residents
The First People's Hospital of Jingzhou