Early Arthroscopic Partial Meniscectomy(APM)

Consultant of Shenzhen People's Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tear
• Intervention / Treatment: Procedure: early APM; Procedure: delayed APM

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Guo, Master; Phone Number: 13897830515; Email: 373073766@qq.com
• Study Contact Backup: Name: Zipeng Zhou, Master; Phone Number: 15841659784; Email: zhouzipeng1990@163.com

Study Locations

• China
  • Liaoning
    • Jinzhou, Liaoning, China, 121000
      • Recruiting
      • First Affiliated Hospital of Jinzhou Medical University
      • Contact: Yue Guo, Master; Phone Number: 13897830515; Email: 373073766@qq.com
      • Principal Investigator: Shuai Li, Master
      • Principal Investigator: Wei Lu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: early APM; Early APM group were patients have knee syndrome within 3 to 6 months	Procedure: early APM; Early APM group were patients have knee syndrome within 3 to 6 months; Other Names: Early arthroscopic partial meniscectomy
PLACEBO_COMPARATOR: delayed APM; delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months	Procedure: delayed APM; delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months; Other Names: delayed arthroscopic partial meniscectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The First People's Hospital of Jingzhou

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2018
• Primary Completion (ANTICIPATED): December 5, 2022
• Study Completion (ANTICIPATED): December 7, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (ACTUAL): November 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: APM TIME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No