Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function
First Affiliated Hospital of Jinzhou Medical Universtiy
1 other identifier
observational
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 3, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedJune 10, 2021
June 1, 2021
2.8 years
June 3, 2021
June 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
KOOS Pain subscale
up to 12 month
Symptoms subscale
up to 12 month
Activities of Daily Living subscale
up to 12 month
Sport and Recreation function subscale
up to 12 month
knee-related Quality of Life subscale
up to 12 month
- +1 more secondary outcomes
Study Arms (2)
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
Interventions
Eligibility Criteria
participants from Jinzhou City, west of Liaoning Province
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyu Wang, Doctor
The First People's Hospital of Jingzhou
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief residents
Study Record Dates
First Submitted
June 3, 2021
First Posted
June 10, 2021
Study Start
June 1, 2017
Primary Completion
March 25, 2020
Study Completion
March 1, 2021
Last Updated
June 10, 2021
Record last verified: 2021-06