Metabolic Syndrome and Degenerate Meniscus Tears

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Meniscus; Degeneration

• Registration Number: NCT04837456
• Lead Sponsor: The First People's Hospital of Jingzhou

Brief Summary

The aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or delayed APM effect on MetS patients with Degenerate menisucus lesions.

Detailed Description

The investigators recruited 180 patients with Metabolic Syndrome and knee symptoms with degenerate meniscus lesions by MRI from orthopaedics department from June 2017 to March 2020 at First Affiliated Hospital of Jinzhou Medical University. Participants were diagnosed with MetS and degenerate meniscus tear with a mild or no osteoarthritis KL\<2 verified by X ray. Participants were randomly dividied into calorie-restricted diet and exercise intervention group; libitum diet and waiting list control group; early APM (syndrome within 3-6 months) group or a delayed APM(syndrome more than 6 months) group as a computer sequenced number. The primary outcome was the change in metabolic syndrome components and knee function score of WOMAC, KOOS,WOMET,IKDC were determined by two fixed orthopadic surgeons who were blinded to the intervention.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2020-03-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-06
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Must be age between 35 and 70 years old;
• Clinical diagnosis of metabolic syndrome;
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee KOOS4	up to 12 months	the Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems) life (KOOs 4 ) were assessed.One of the most frequently-used knee-specific PROMs is the Knee injury and Osteoarthritis Outcome Score (KOOS) which was developed for adults who have knee OA or knee injuries.KOOS holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
weight	up to 12 months	weight in kilograms
height	up to 12 months	height in meters
triglyceride	up to 12 months	triglyceride in mmol/L
LDL-C	up to 12 months	low-density lipoprotein cholesterol in mmol/L
β-2 microglobulin	up to 12 months	β-2 microglobulin in mg/L
the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	up to 12 months	the WOMAC score is a disease-specific self-report multidimensional questionnare assesing pain, siffness, and physical functional disability.WOMAC scores range from 0 to 100, with higher scores indicating worse physical function.
BMI	up to 12 months	BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m\^2
cardio vascular disease history	up to 12 months	cardio vascular disease history
Kellgren-Lawrence grade	up to 12 months	A Kellgren-Lawrence grade of 0 indicates no osteoarthritis, a grade of 1 with questionable osteophyte indicates possible osteoarthritis; a grade of 2 with definite osteophyte and no joint-space narrowing indicates mild osteoarthritis, a grade of 3 with ≤50% joint-space narrowing or a grade of 4 with\>50% joint-space narrowing indicates severe osteoarthritis were excluded.
Lysholm knee score	up to 12 months	The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).	up to 12 months	The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear. The questionnaire contains 18 items scored in 1 of 3 ways: 11-point Likert scale, 5-point Likert scale, or dichotomous yes or no. After the participant completes the questionnaire, the scores are summed, and the total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function.
The WOMET score	up to 12 months	The WOMET is a meniscus-specific health-related quality-of-life instrument, validated especially for patients with a degenerative meniscal tear.The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items ad-dressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possi- ble score, and 0 is the worst possible score.
waist circumstance	up to 12 months	waist circumstance in centimeter
diastolic blood pressure	up to 12 months	diastolic blood pressure in mm Hg
fast blood glucose	up to 12 months	fast blood glucose in mmol/L
total Cholesterol	up to 12 months	total Cholesterol in mmol/L
diabetes history	up to 12 months	diabetes history
hypertension history	up to 12 months	hypertension history
systolic blood pressure	up to 12 months	systolic blood pressure in mm Hg
HDL-C	up to 12 months	high-density lipoprotein cholesterol in mmol/L

Trial Locations

Locations (1)

First Affiliated Hospital of Jinzhou Medical University; 🇨🇳 Jinzhou, Liaoning, China