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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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

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)

November 30, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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