A Study on Different Treatments for Knee Osteoarthritis Caused by Damaged Roots of the Medial Meniscus.

November 26, 2024 updated by: Yinxian Yu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Comparison of Different Treatment Strategies for Root Injury Behind the Medial Meniscus to Delay the Progression of Knee Osteoarthritis: a Prospective Cohort Study

Medial meniscus posterior root tears (MMPRT) account for 20% or more of all meniscus tears, but the diagnosis and treatment of this condition continues to plague the general population due to the complexity of the diagnosis and uncertainty of the treatment. Early as well as timely diagnosis and treatment is one of the effective ways to avoid accelerated knee degeneration. Based on this study, our team is going to conduct a clinical study on posterior medial meniscus tear, combining Magnetic Resonance Imaging(MRI) to dynamically assess the changes of meniscus and articular cartilage surface after the injury, and selecting a specific patient group to carry out different therapeutic interventions, which mainly include conservative treatment, partial meniscectomy, and meniscal repair, in order to clarify the effects of different treatment modalities on the articular cartilage after the posterior meniscus tear, and to help to delay the degeneration of knee joints. This is to clarify the effects of different treatment modalities on the articular cartilage after posterior medial meniscus tears and to provide appropriate advice for delaying the progression of osteoarthritis of the knee.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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 (Estimated)

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.
69

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with posterior root injuries of the medial meniscus

Description

Inclusion Criteria:

  1. Clinical diagnosis of posterior root tear of the medial meniscus;
  2. Patients with K-L classification ≤ grade II;
  3. The age range of 50-65 years old;
  4. International Cartilage Repair Society (ICRS) Modified Magnetic Resonance Imaging Grading System ≤ Grade 2;
  5. International Cartilage Repair Society (ICRS) arthroscopic grading system ≤ grade 2;
  6. Knee joint mobility ≥90°;
  7. Inversion deformity ≤10°;
  8. Must be able to complete follow-up MRI within 2 years after knee meniscus surgery;
  9. Must be able to complete clinical data;

Exclusion Criteria:

  1. Can not participate in this study;
  2. Patients with concomitant meniscal injuries elsewhere;
  3. knee joint infection disease;
  4. Osteoporosis disease;
  5. Patients with previous history of knee surgery;
  6. Knee joint instability disease;
  7. Severe KOA disease;
  8. Can not cooperate with MRI detection;
  9. Cannot tolerate the surgery;
  10. Those who cannot tolerate the arthroscopic knee surgery;
  11. Neuromuscular system pathology disease;

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.
Conservative treatment group
Non-steroidal anti-inflammatory and analgesic drugs
Arthroscopic partial meniscectomy group
Arthroscopically, the damaged free meniscus is trimmed, ground, and partially resected;
Procedure: Arthroscopic meniscus surgery
Comparison of the incidence of osteoarthritis with conservative treatment as well as arthroscopic partial resection as well as arthroscopic repair surgery for a condition known as posterior meniscus root injury.
Arthroscopic meniscus suture repair group
Arthroscopic download of the posterior meniscus root injury, placement of sutures through the bone tunnel to fix the meniscus, and then cutting it with a knot to complete the meniscus suture repair.
Procedure: Arthroscopic meniscus surgery
Comparison of the incidence of osteoarthritis with conservative treatment as well as arthroscopic partial resection as well as arthroscopic repair surgery for a condition known as posterior meniscus root injury.

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
Time Frame
the incidence of KOA
Time Frame: 30th November 2024 -30th November 2027
30th November 2024 -30th November 2027

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Articular cartilage T2-mapping value
Time Frame: 30th November 2024 -30th November 2027
Articular cartilage T2 mapping values, post-standardised range 0-1
30th November 2024 -30th November 2027

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS (visual analogue scale)，VAS score
Time Frame: 30th November 2024 -30th November 2027
The specific scoring method is to draw a 10 cm horizontal line on top of the paper, with 0 at one end of the line indicating no pain, 10 at the other end indicating severe pain, and the middle portion indicating varying degrees of pain.
30th November 2024 -30th November 2027
Lysholm score
Time Frame: 30th November 2024 -30th November 2027
The score consists of eight indicators: pain (25 points), instability (25 points), atresia (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting posture (5 points), and the use of supports (5 points), with a total score of 100, with higher scores representing better knee function. 95 points or more is considered excellent, 94-85 points is good, 84-65 points is fair, and less than 65 points is poor. A score of less than 65 is poor.
30th November 2024 -30th November 2027
HSS (Hospital for Special Surgery) Score
Time Frame: 30th November 2024 -30th November 2027
The score is out of 100 and consists of pain (30 points), function (22 points including walking and stair climbing), knee mobility (18 points), muscle strength (10 points), flexion deformity (10 points), joint stability (10 points), and deductions (-5 points). The higher the score, the better the knee function.
30th November 2024 -30th November 2027

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.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
November 30, 2024

Primary Completion (Estimated)

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.
November 30, 2027

Study Completion (Estimated)

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 15, 2027

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).
November 24, 2024

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.
November 26, 2024

First Posted (Estimated)

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.
November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
November 27, 2024

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.
November 26, 2024

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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • IIT2024-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decide whether to share data based on the level of completion of the project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Osteoarthritis

Clinical Trials on Arthroscopic meniscus surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings