Early Arthroscopic Partial Meniscectomy(APM)

Meniscus Tear Clinical Trial

Official title:

Consultant of Shenzhen People's Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114694
• Other study ID #: APM TIME
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 7, 2022

Study information

• Verified date: November 2022
• Source: The First People's Hospital of Jingzhou
• Contact: Yue Guo, Master
• Phone: 13897830515
• Email: 373073766[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.

Description:

Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 7, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• 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;

• Clinical diagnosis of degnerate meniscus tears;

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

• Meniscus Tear

Intervention

Procedure:
• early APM
Early APM group were patients have knee syndrome within 3 to 6 months
• delayed APM
delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months

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	Knee KOOS score	The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Primary	IKDC score	The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Primary	waist circumstance	midway between the lowest rib and the iliac crest, using an anthropometric tape	at baseline
Primary	SBP	systolic blood pressure	at baseline
Primary	DBP	diastolic blood pressure	at baseline
Primary	TC	serum total cholesterol (TC)	at baseline
Primary	TG	serum triglycerides (TG)	at baseline
Primary	LDL	serum low-density lipoprotein cholesterol (LDL-C)	at baseline
Primary	HDL	serum high-density lipoprotein cholesterol (HDL-C)	at baseline
Primary	FBG	serum fast blood glucose(FBG)	at baseline
Primary	BMI	BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2	at baseline
Primary	K-L grade	Kellgren-Lawrence (K/L) grade	at baseline
Secondary	pain score	The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Secondary	symptoms score	The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Secondary	activities of daily living score	The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Secondary	function in sport and recreation score	The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month
Secondary	knee related quality of life score	The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)	up to 12 month