Arthroscopic Partial Meniscectomy Time Window

March 10, 2023 updated by: Shenzhen People's Hospital

Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions

The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Jinzhou, Liaoning, China, 121000
        • Recruiting
        • First Affiliated Hospital of Jinzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • • Clinical diagnosis of degenerative meniscus lesions based on knee MRI

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early APM
early APM within 3 and 6 month knee pain symptoms
Procedure: early APM
early APM within 3 and 6 month knee pain symptoms
Active Comparator: delayed APM
delayed APM within 6 and 12 month knee pain symptoms
Procedure: delayed APM
delayed APM within 6 and 12 month knee pain symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
Time Frame: change from baseline up to 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
change from baseline up to 12 months
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
Time Frame: change from baseline up to 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade change
Time Frame: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade via X ray
change from baseline up to 12 months
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change
Time Frame: change from baseline up to 12 months
Te WOMAC is a self assessed health status scale for patients consisting of 24 items in three subscales of pain (5 items), stiffness (2 items), and physical function (17 items). All items are scored from 0 (asymptomatic) to 4 (very severe), and the total score ranges from 0 to 96, with higher scores indicating more severe symptoms
change from baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS pain score change
Time Frame: change from baseline up to 12 months
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
change from baseline up to 12 months
KOOS symptoms score change
Time Frame: change from baseline up to 12 months
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
change from baseline up to 12 months
KOOS activities of daily living score change
Time Frame: change from baseline up to 12 months
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
change from baseline up to 12 months
KOOS function in sport and recreation score change
Time Frame: change from baseline up to 12 months
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
change from baseline up to 12 months
KOOS knee related quality of life score change
Time Frame: change from baseline up to 12 months
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
change from baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Investigators

  • Principal Investigator: Hongyu Wang, Doctor, Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2020

Primary Completion (Anticipated)

July 5, 2023

Study Completion (Anticipated)

August 28, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SZlesions

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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