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Clinical Trials/NCT05655429
NCT05655429
Recruiting
Not Applicable

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

Shenzhen People's Hospital1 site in 1 country120 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Medial Meniscus Tears
Sponsor
Shenzhen People's Hospital
Enrollment
120
Locations
1
Primary Endpoint
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
August 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shenzhen People's Hospital
Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

the Knee Injury and Osteoarthritis Outcome Score (KOOS) change

Time Frame: 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

Time Frame: change from baseline up to 12 months

systolic blood pressure /mmHg

Kellgren-Lawrence (K/L) grade change

Time Frame: change from baseline up to 12 months

Kellgren-Lawrence (K/L) grade

high-density lipoprotein cholesterol (HDL-C) change

Time Frame: change from baseline up to 12 months

serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)

fast blood glucose(FBG) change

Time Frame: change from baseline up to 12 months

serum fast blood glucose(FBG) (mmol/L)

serum triglycerides (TG) change

Time Frame: change from baseline up to 12 months

serum triglycerides (TG) (mmol/L)

low-density lipoprotein cholesterol (LDL-C) change

Time Frame: change from baseline up to 12 months

serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)

the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change

Time Frame: 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.

waist circumstance change

Time Frame: change from baseline up to 12 months

waist circumstance (cm)

diastolic blood pressure change

Time Frame: change from baseline up to 12 months

diastolic blood pressure/mmHg

serum total cholesterol (TC) change

Time Frame: change from baseline up to 12 months

serum total cholesterol (TC) (mmol/L)

Body mass index change

Time Frame: change from baseline up to 12 months

Body mass index(BMI) weight/height square (kg/㎡)

Secondary Outcomes

  • activities of daily living score change(change from baseline up to 12 months)
  • pain score change(change from baseline up to 12 months)
  • knee related quality of life score change(change from baseline up to 12 months)
  • symptoms score change(change from baseline up to 12 months)
  • function in sport and recreation score change(change from baseline up to 12 months)

Study Sites (1)

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