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NCT Number: NCT04921202

Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Metabolic syndrome and meniscus injuries

Other

Metabolic syndrome

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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).

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Jingzhou

Other

Registry information

Official study title

First Affiliated Hospital of Jinzhou Medical Universtiy

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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