NCT05114694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

4.9 years

First QC Date

November 5, 2021

Last Update Submit

November 9, 2022

Conditions

Meniscus Tear

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (5)

  • pain score

    up to 12 month

  • symptoms score

    up to 12 month

  • activities of daily living score

    up to 12 month

  • function in sport and recreation score

    up to 12 month

  • knee related quality of life score

    up to 12 month

Study Arms (2)

early APM

EXPERIMENTAL

Early APM group were patients have knee syndrome within 3 to 6 months

Procedure: early APM

delayed APM

PLACEBO COMPARATOR

delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months

Procedure: delayed APM

Interventions

early APMPROCEDURE

Early APM group were patients have knee syndrome within 3 to 6 months

Also known as: Early arthroscopic partial meniscectomy
early APM
delayed APMPROCEDURE

delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months

Also known as: delayed arthroscopic partial meniscectomy
delayed APM

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be age between 35 and 70 years old;
  • Clinical diagnosis of metabolic syndrome;
  • Clinical diagnosis of degnerate meniscus tears;

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

RECRUITING

Central Study Contacts

Yue Guo, Master

CONTACT

13897830515373073766@qq.com

Zipeng Zhou, Master

CONTACT

15841659784zhouzipeng1990@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief residents

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 10, 2021

Study Start

January 15, 2018

Primary Completion

December 5, 2022

Study Completion

December 7, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

CN(1)