Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function

Metabolic Syndrome Clinical Trial

Official title:

First Affiliated Hospital of Jinzhou Medical Universtiy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921202
• Other study ID #: Jinzhou Medical University
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2021
• Source: The First People's Hospital of Jingzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Studies have suggested that Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis. However, no studies demonstrate the relationship between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee function.The aim is to detect the correlation between obese patients with metabolic syndrome and degenerate meniscus injuries.

Description:

Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis. However, no studies demonstrate the relationship between patients with metabolic syndrome and degenerate meniscus lesions or knee function. Participants were recruited from First Affiliated Hospital of Jinzhou Medical University. 100 BMI<24 people without Metabolic syndrome volunteers aged between 35-70 years old and 80 Metabolic syndrome patients with BMI>27 were included in the study. Obese patients with MetS were assessed knee function and degenerate meniscus tears verified by magnetic resonance imaging. And patients with a mild or no osteoarthritis with Kellgren and Lawrence grade<2 verified by X ray. We tested the relationship between metabolic syndrome and degenerate meniscus lesions. Obese patients with MetS and volunteers were detected by Mcmurry's test and MRI image to measure degeneration grade of meniscus tears. Number of MetS components were accounted and the knee function KOOS, IKDC score or degenerate meniscus tears were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 1, 2021
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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;
• BMI score more than 27 or less than 24
• Clinical diagnosis of 3 grade degneration meniscus leisons;

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 Arthritis
• Meniscus Lesion
• Metabolic Syndrome
• Obesity, Abdominal
• Syndrome

Intervention

Other:
• Metabolic syndrome and meniscus injuries
Metabolic syndrome

Locations

Country	Name	City	State
China	First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Jingzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Knee injury and Osteoarthritis Outcome Score (KOOS) total	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).	up to 12 month
Primary	The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score	The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score to determine the meniscus function. The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear[36, 37] [38]. The 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.	up to 12 month
Secondary	KOOS Pain subscale	Pain including 9 items,The minimum value is 0 and maximum values subscale is 100, the scored separately from zero (extreme knee problems) to 100 (no knee problems)	up to 12 month
Secondary	Symptoms subscale	Symptoms including 7 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)	up to 12 month
Secondary	Activities of Daily Living subscale	Activities of Daily Living including 17 items,The minimum value is 0 and maximum values subscale is100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).	up to 12 month
Secondary	Sport and Recreation function subscale	Sport and Recreation function including 5 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).	up to 12 month
Secondary	knee-related Quality of Life subscale	knee-related Quality of Life including 4 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems).	up to 12 month
Secondary	KOOS4	KOOS4, The minimum value is 0 and maximum values subscale is100. KOOS4 defined as the average score for four of the five knee injury and osteoarthritis outcome score (KOOS) validity for patients with meniscal tears and osteoarthritis.	up to 12 month