Clinical trial NCT05655429: Physical Therapy vs Arthroscopic Partial Meniscectomy
Official title: Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Medial Meniscus Tears
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
timeFrame: change from baseline up to 12 months
measure: the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
timeFrame: change from baseline up to 12 months
measure: waist circumstance change
timeFrame: change from baseline up to 12 months
measure: systolic blood pressure change
timeFrame: change from baseline up to 12 months
measure: diastolic blood pressure change
timeFrame: change from baseline up to 12 months
measure: serum total cholesterol (TC) change
timeFrame: change from baseline up to 12 months
measure: serum triglycerides (TG) change
timeFrame: change from baseline up to 12 months
measure: low-density lipoprotein cholesterol (LDL-C) change
timeFrame: change from baseline up to 12 months
measure: high-density lipoprotein cholesterol (HDL-C) change
timeFrame: change from baseline up to 12 months
measure: fast blood glucose(FBG) change
timeFrame: change from baseline up to 12 months
measure: Body mass index change
timeFrame: change from baseline up to 12 months
measure: Kellgren-Lawrence (K/L) grade change
timeFrame: change from baseline up to 12 months
Secondary outcomes:
measure: pain score change
timeFrame: change from baseline up to 12 months
measure: symptoms score change
timeFrame: change from baseline up to 12 months
measure: activities of daily living score change
timeFrame: change from baseline up to 12 months
measure: function in sport and recreation score change
timeFrame: change from baseline up to 12 months
measure: knee related quality of life score change
timeFrame: change from baseline up to 12 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
References: