EPOS Discoid Meniscus (DiMe) Project (DiMe)

July 24, 2025 updated by: University of Milano Bicocca

EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol

The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a multicentric international prospective cohort study. All eligible consecutive patients will be identified prospectively by the local participating clinical teams according to Inclusion/Exclusion Criteria. Prospective data entry is mandatory.

Data collection will be conducted in three phases:

  • Phase 1 will register patients to the study, document symptomatic DM, collect the details of patient demographics, sport characteristics, PROMS, imaging classification and consent of the patient's legal representatives. Once the patient has reached the age of majority, the date of his/her own consent will be recorded.
  • Phase 2 will register surgical treatment and arthroscopic video and photographs collected during surgery, collect intraoperative DM instability, arthroscopic classification, and surgical details. Post-operative complication will also be collected.
  • Phase 3 will collect short-, medium- and long-term outcome data. Short follow-up data collection will plan at 1 month follow-up then 3 and 6-months follow-up. Then annual data collection will be performed.

The foreseen timeframe of follow-up will be 15 years for each patient. At the end of the 15-year follow-up, the data will be stored for an additional 10 years before being deleted. Data will be recorded if the patients are willing to comply with the annual data collection. Should the DiMe Project be terminated at one stage, the data will be stored for 10 years after termination of the project before being deleted.

Study Type

Observational

Enrollment (Estimated)

500

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 Locations

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children diagnosed with symptomatic DM confirmed on the basis of physical examination and MRI

Description

Inclusion Criteria:

  • symptomatic DM confirmed by a senior orthopedic surgeon based on physical examination and MRI
  • age less than eighteen years
  • informed consent freely granted and acquired before the start of the study from legal representative

Exclusion Criteria:

  • concomitant or previous knee surgeries
  • concomitant ligament knee injury that requires a surgical treatment
  • concomitant fractures
  • inflammatory or arthritic diseases.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
Time Frame: Enrollment period (approximately 5 years)
Enrollment period (approximately 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to return to sport (months) among the three types of DM tear according to Ahn classification.
Time Frame: Entire study duration (approximately 20 years)
Entire study duration (approximately 20 years)
Tegner activity level scale (0-10) among the three types of DM tear according to Ahn classification.
Time Frame: Entire study duration (approximately 20 years)
Tegner activity level scale:0=Sick leave or disability pension because of knee problems 10=Competitive sports Soccer - national and international elite
Entire study duration (approximately 20 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical treatment in each type of DM, according to Watanabe and Ahn classifications
Time Frame: Enrollment period (approximately 5 years)
Enrollment period (approximately 5 years)
Pedi-IKDC related to anthropometric features and anamnestic characteristics.
Time Frame: Enrollment period (approximately 5 years)
The Pediatric International Knee Documentation Committee (Pedi-IKDC) Subjective Knee Evaluation Form
Enrollment period (approximately 5 years)
DM healing (timing of early phase, remodeling (high tissue enhancement), maturation measured in months from surgery - all measured with serial MRIs)
Time Frame: Entire study duration (approximately 20 years)
Entire study duration (approximately 20 years)

Collaborators and Investigators

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

Sponsor

University of Milano Bicocca

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 (Actual)

September 8, 2022

Primary Completion (Estimated)

September 1, 2042

Study Completion (Estimated)

September 1, 2042

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DiMe

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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