Physical Therapy vs Arthroscopic Partial Meniscectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Medial Meniscus Tears
• Intervention / Treatment: Procedure: physical therapy; Procedure: arthroscopic partial meniscectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 121000
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: Yu Luo, Master; Phone Number: 18841609587; Email: zhzm622@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): August 2, 2023
• Study Completion (Anticipated): August 10, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ShenzhenPH meniscus001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No