Clinical Related Study on Surgical Treatment of Knee Joint Meniscus Injury

July 4, 2021 updated by: Peking University Third Hospital
Through the analysis of the data of 8094 patients with knee meniscus injury before December 31, 2008 and more patients with partial meniscus resection, subtotal resection and total resection, we can understand the gender difference and ratio of medial and lateral meniscus injuries. Differences, differences in locations, differences in tearing methods, differences in surgical methods, and the course of the disease affect the meniscus injury and surgical methods, and further affect the patient's knee degeneration imaging, accompanying cartilage injury, knee osteoarthritis, Partial resection, subtotal resection and meniscus regeneration after total resection, imaging and secondary arthroscopic exploration (Second-Look) were studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Through the data of 8094 patients with knee meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Beijing Medical University before December 31, 2008, and the patients who underwent meniscus suture, partial resection, subtotal resection, and total resection. Analyze and understand the influence of gender difference, ratio difference, position difference, tearing method difference, surgical method difference and disease course on the meniscus injury situation and operation method of the internal and lateral meniscus injury. Observation and research will also be conducted on reports of knee cartilage injury, knee osteoarthritis, and meniscus regeneration after partial meniscus resection, subtotal resection and total resection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8778

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
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Institute of Sports Medicine, Peking University Third Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

8778 patients with meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Peking University before December 31, 2008 and patients who underwent meniscus suture, partial resection, subtotal resection, or total resection afterwards

Description

Inclusion Criteria:

Before December 31, 2008, patients who underwent surgery for meniscus injury in this institute and patients who underwent meniscus suture, partial resection, subtotal resection, and total resection.

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Meniscus Suture
The patient underwent meniscus suture surgery
Procedure: Meniscus Suture
Patients with knee joint meniscus injury undergoing meniscus suture
Partial meniscus resection
The patient underwent partial meniscus resection
Procedure: Partial meniscus resection
Patients with knee joint meniscus injury undergoing partial meniscus resection
Subtotal meniscus resection
The patient underwent Subtotal meniscus resection
Procedure: Subtotal meniscus resection
Patients with knee joint meniscus injury undergoing subtotal meniscus resection
Complete meniscectomy
The patient underwent complete meniscectomy
Procedure: Complete meniscectomy
Patients with knee joint meniscus injury undergoing complete meniscectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Meniscus injury site
Time Frame: During operation
Observe the meniscus injury site during the operation, which is divided into: medial and lateral anterior horn, medial and lateral body, medial and lateral posterior horn, medial and lateral disc.
During operation
Types of Meniscus Injury
Time Frame: During operation
The types of meniscus injuries were observed during the operation, which were divided into longitudinal fissure, oblique fissure, spallation, radial fissure, and barrel shank tear.
During operation
Meniscus surgery method
Time Frame: During operation
Meniscus surgery methods include: partial resection, subtotal resection, total resection, and suture.
During operation
Cartilage damage
Time Frame: During operation
The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
During operation
Cartilage damage
Time Frame: 7 years after surgery
Second-look after operation to observe whether the cartilage is damaged. The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
7 years after surgery
Meniscus regeneration
Time Frame: 7 years after surgery
Second-look after operation to observe whether the meniscus is regenerating. The Meniscus regeneration is evaluated as yes or no, in which the meniscus shape is complete and no tear is defined as yes, and other conditions are defined as no.
7 years after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00006761-2015159

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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