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NCT Number: NCT05580315

EPOS Discoid Meniscus (DiMe) Project

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.

    Time frame: Enrollment period (approximately 5 years)

Secondary outcomes

  1. 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)

  2. 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

Other outcomes

  1. Surgical treatment in each type of DM, according to Watanabe and Ahn classifications

    Time frame: Enrollment period (approximately 5 years)

  2. 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

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Turati, MD

CONTACT

[email protected]

+39 0392333021

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Acronym: DiMe

Important dates

Study start
2022
Primary completion
2042
Study completion
2042
First posted
Oct 14, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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