- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04962555
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
Recruiting
Conditions
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
Observational
Enrollment (Anticipated)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Meniscus Suture
The patient underwent meniscus suture surgery
|
Patients with knee joint meniscus injury undergoing meniscus suture
|
|
Partial meniscus resection
The patient underwent partial meniscus resection
|
Patients with knee joint meniscus injury undergoing partial meniscus resection
|
|
Subtotal meniscus resection
The patient underwent Subtotal meniscus resection
|
Patients with knee joint meniscus injury undergoing subtotal meniscus resection
|
|
Complete meniscectomy
The patient underwent complete meniscectomy
|
Patients with knee joint meniscus injury undergoing complete meniscectomy
|
What is the study measuring?
Primary Outcome Measures
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
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)
August 1, 2016
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
July 4, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Actual)
July 15, 2021
Last Update Submitted That Met QC Criteria
July 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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