Physical Therapy vs Arthroscopic Partial Meniscectomy

Study Overview
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Brief Summary
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The purpose was to assess knee function outcomes between physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up.

Detailed Description
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Metabolic syndrome were diagnosed with abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure and widely prevalence all around the world.MetS patients were always correlated with knee osteoarthritis or cartilage volume loss. For MetS patients with DMLs, whether physical therapy was non-inferior to APM in knee function and MetS components was unknown.

Official Title
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Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions

Conditions
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Knee Medial Meniscus Tears

Intervention / Treatment
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* Procedure: physical therapy
* Procedure: arthroscopic partial meniscectomy


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 degenerative meniscus lesions; Patients who has knee pain history Knee symptoms consistent with DMLs verified on MRI eligible for arthroscopic partial meniscectomy surgery by the examining orthopedic surgeons. 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical therapy<br>Physical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. | Procedure: physical therapy<br>* The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week.<br>|
| Active Comparator: arthroscopic partial meniscectomy<br>The torn meniscus and unstable part were removed with arthroscopic instruments. | Procedure: arthroscopic partial meniscectomy<br>* Arthroscopic partial meniscectomy surgery procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Knee Injury and Osteoarthritis Outcome Score (KOOS) change | 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) | change from baseline up to 12 months | 
| the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change | 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. | change from baseline up to 12 months | 
| waist circumstance change | waist circumstance (cm) | change from baseline up to 12 months | 
| systolic blood pressure change | systolic blood pressure /mmHg | change from baseline up to 12 months | 
| diastolic blood pressure change | diastolic blood pressure/mmHg | change from baseline up to 12 months | 
| serum total cholesterol (TC) change | serum total cholesterol (TC) (mmol/L) | change from baseline up to 12 months | 
| serum triglycerides (TG) change | serum triglycerides (TG) (mmol/L) | change from baseline up to 12 months | 
| low-density lipoprotein cholesterol (LDL-C) change | serum low-density lipoprotein cholesterol (LDL-C) (mmol/L) | change from baseline up to 12 months | 
| high-density lipoprotein cholesterol (HDL-C) change | serum high-density lipoprotein cholesterol (HDL-C) (mmol/L) | change from baseline up to 12 months | 
| fast blood glucose(FBG) change | serum fast blood glucose(FBG) (mmol/L) | change from baseline up to 12 months | 
| Body mass index change | Body mass index(BMI) weight/height square (kg/㎡) | change from baseline up to 12 months | 
| Kellgren-Lawrence (K/L) grade change | Kellgren-Lawrence (K/L) grade | change from baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score change | The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula. | change from baseline up to 12 months | 
| symptoms score change | The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula. | change from baseline up to 12 months | 
| activities of daily living score change | The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula | change from baseline up to 12 months | 
| function in sport and recreation score change | The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula | change from baseline up to 12 months | 
| knee related quality of life score change | The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula | change from baseline up to 12 months |