Physical Therapy vs Arthroscopic Partial Meniscectomy
- Conditions
- Knee Medial Meniscus Tears
- Interventions
- Procedure: arthroscopic partial meniscectomyProcedure: physical therapy
- Registration Number
- NCT05655429
- Lead Sponsor
- Shenzhen People's Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
-
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.
-
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arthroscopic partial meniscectomy arthroscopic partial meniscectomy The torn meniscus and unstable part were removed with arthroscopic instruments. physical therapy physical therapy Physical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months.
- Primary Outcome Measures
Name Time Method the Knee Injury and Osteoarthritis Outcome Score (KOOS) change 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)
systolic blood pressure change change from baseline up to 12 months systolic blood pressure /mmHg
Kellgren-Lawrence (K/L) grade change change from baseline up to 12 months Kellgren-Lawrence (K/L) grade
high-density lipoprotein cholesterol (HDL-C) change change from baseline up to 12 months serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
fast blood glucose(FBG) change change from baseline up to 12 months serum fast blood glucose(FBG) (mmol/L)
serum triglycerides (TG) change change from baseline up to 12 months serum triglycerides (TG) (mmol/L)
waist circumstance change change from baseline up to 12 months waist circumstance (cm)
the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change 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.
diastolic blood pressure change change from baseline up to 12 months diastolic blood pressure/mmHg
serum total cholesterol (TC) change change from baseline up to 12 months serum total cholesterol (TC) (mmol/L)
low-density lipoprotein cholesterol (LDL-C) change change from baseline up to 12 months serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Body mass index change change from baseline up to 12 months Body mass index(BMI) weight/height square (kg/㎡)
- Secondary Outcome Measures
Name Time Method activities of daily living score change change from baseline up to 12 months 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
pain score change change from baseline up to 12 months 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.
knee related quality of life score change change from baseline up to 12 months 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
symptoms score change change from baseline up to 12 months 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.
function in sport and recreation score change change from baseline up to 12 months 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
Trial Locations
- Locations (1)
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China