Physical Therapy vs Arthroscopic Partial Meniscectomy

Knee Medial Meniscus Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655429
• Other study ID #: ShenzhenPH meniscus001
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: March 2023
• Source: Shenzhen People's Hospital
• Contact: Hongyu Wang, Doctor
• Phone: 18241651300
• Email: wanghongyu790039663[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 10, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Knee Medial Meniscus Tears

Intervention

Procedure:
• physical therapy
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for =2 day per week.
• arthroscopic partial meniscectomy
Arthroscopic partial meniscectomy surgery procedure

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	waist circumstance change	waist circumstance (cm)	change from baseline up to 12 months
Primary	systolic blood pressure change	systolic blood pressure /mmHg	change from baseline up to 12 months
Primary	diastolic blood pressure change	diastolic blood pressure/mmHg	change from baseline up to 12 months
Primary	serum total cholesterol (TC) change	serum total cholesterol (TC) (mmol/L)	change from baseline up to 12 months
Primary	serum triglycerides (TG) change	serum triglycerides (TG) (mmol/L)	change from baseline up to 12 months
Primary	low-density lipoprotein cholesterol (LDL-C) change	serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)	change from baseline up to 12 months
Primary	high-density lipoprotein cholesterol (HDL-C) change	serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)	change from baseline up to 12 months
Primary	fast blood glucose(FBG) change	serum fast blood glucose(FBG) (mmol/L)	change from baseline up to 12 months
Primary	Body mass index change	Body mass index(BMI) weight/height square (kg/?)	change from baseline up to 12 months
Primary	Kellgren-Lawrence (K/L) grade change	Kellgren-Lawrence (K/L) grade	change from baseline up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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