Early Arthroscopic Partial Meniscectomy(APM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Consultant of Shenzhen People's Hospital

Conditions
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Meniscus Tear

Intervention / Treatment
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* Procedure: early APM
* Procedure: delayed APM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Must be age between 35 and 70 years old; Clinical diagnosis of metabolic syndrome; Clinical diagnosis of degnerate meniscus tears; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early APM<br>Early APM group were patients have knee syndrome within 3 to 6 months | Procedure: early APM<br>* Early APM group were patients have knee syndrome within 3 to 6 months<br>* Other names: Early arthroscopic partial meniscectomy;|
| Placebo Comparator: delayed APM<br>delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months | Procedure: delayed APM<br>* delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months<br>* Other names: delayed arthroscopic partial meniscectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee KOOS score | 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) | up to 12 month | 
| IKDC score | 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) | up to 12 month | 
| waist circumstance | midway between the lowest rib and the iliac crest, using an anthropometric tape | at baseline | 
| SBP | systolic blood pressure | at baseline | 
| DBP | diastolic blood pressure | at baseline | 
| TC | serum total cholesterol (TC) | at baseline | 
| TG | serum triglycerides (TG) | at baseline | 
| LDL | serum low-density lipoprotein cholesterol (LDL-C) | at baseline | 
| HDL | serum high-density lipoprotein cholesterol (HDL-C) | at baseline | 
| FBG | serum fast blood glucose(FBG) | at baseline | 
| BMI | BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2 | at baseline | 
| K-L grade | Kellgren-Lawrence (K/L) grade | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems) | up to 12 month | 
| symptoms score | The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems) | up to 12 month | 
| activities of daily living score | The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems) | up to 12 month | 
| function in sport and recreation score | The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems) | up to 12 month | 
| knee related quality of life score | The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems) | up to 12 month |