Early Arthroscopic Partial Meniscectomy(APM)

NCT ID: NCT05114694

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2022-12-07

Brief Summary

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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

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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.

Conditions

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Meniscus Tear

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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early APM

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

Group Type EXPERIMENTAL

early APM

Intervention Type PROCEDURE

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

Group Type PLACEBO_COMPARATOR

delayed APM

Intervention Type PROCEDURE

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

Interventions

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early APM

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

Intervention Type PROCEDURE

delayed APM

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

Intervention Type PROCEDURE

Other Intervention Names

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Early arthroscopic partial meniscectomy delayed arthroscopic partial meniscectomy

Eligibility Criteria

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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;
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First People's Hospital of Jingzhou

OTHER

Sponsor Role lead

Responsible Party

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Hongyu Wang

chief residents

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Guo, Master

Role: CONTACT

13897830515

Zipeng Zhou, Master

Role: CONTACT

15841659784

Facility Contacts

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Yue Guo, Master

Role: primary

13897830515

Ziming Zhao, Master

Role: backup

18841609587

Other Identifiers

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APM TIME

Identifier Type: -

Identifier Source: org_study_id

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