Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function

June 8, 2021 updated by: Hongyu Wang, The First People's Hospital of Jingzhou

First Affiliated Hospital of Jinzhou Medical Universtiy

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.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Liaoning
      • Jinzhou, Liaoning, China, 121000
        • First Affiliated Hospital of Jinzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

participants from Jinzhou City, west of Liaoning Province

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
without metabolic syndrome and BMI<24
100 volunteers aged between 35-70 years old with body mass index(BMI)<24 without Metabolic syndrome
Metabolic Syndrome with BMI>27
80 Metabolic syndrome patients with BMI>27 were included in the study
Metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Knee injury and Osteoarthritis Outcome Score (KOOS) total
Time Frame: up to 12 month
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
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score
Time Frame: up to 12 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS Pain subscale
Time Frame: up to 12 month
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
Symptoms subscale
Time Frame: up to 12 month
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
Activities of Daily Living subscale
Time Frame: up to 12 month
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
Sport and Recreation function subscale
Time Frame: up to 12 month
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
knee-related Quality of Life subscale
Time Frame: up to 12 month
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
KOOS4
Time Frame: up to 12 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

March 25, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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