Early Arthroscopic Partial Meniscectomy(APM)

Not Applicable

Recruiting

• Conditions: Meniscus Tear
• Interventions: Procedure: early APM; Procedure: delayed APM

• Registration Number: NCT05114694
• Lead Sponsor: The First People's Hospital of Jingzhou

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early APM	early APM	Early APM group were patients have knee syndrome within 3 to 6 months
delayed APM	delayed APM	delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months

Primary Outcome Measures

Name	Time	Method
LDL	at baseline	serum low-density lipoprotein cholesterol (LDL-C)
HDL	at baseline	serum high-density lipoprotein cholesterol (HDL-C)
Knee KOOS score	up to 12 month	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)
DBP	at baseline	diastolic blood pressure
TC	at baseline	serum total cholesterol (TC)
FBG	at baseline	serum fast blood glucose(FBG)
IKDC score	up to 12 month	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)
waist circumstance	at baseline	midway between the lowest rib and the iliac crest, using an anthropometric tape
SBP	at baseline	systolic blood pressure
TG	at baseline	serum triglycerides (TG)
BMI	at baseline	BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m\^2
K-L grade	at baseline	Kellgren-Lawrence (K/L) grade

Secondary Outcome Measures

Name	Time	Method
symptoms score	up to 12 month	The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
function in sport and recreation score	up to 12 month	The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
activities of daily living score	up to 12 month	The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
knee related quality of life score	up to 12 month	The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
pain score	up to 12 month	The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)

Trial Locations

Locations (1)

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