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EPOS Discoid Meniscus (DiMe) Project

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05580315
Acronym
DiMe
Enrollment
500
Registered
2022-10-14
Start date
2022-09-08
Completion date
2042-09-01
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discoid Meniscus of Knee

Keywords

discoid meniscus, knee, pediatric, sport medicine

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.Enrollment period (approximately 5 years)

Secondary

MeasureTime frameDescription
Time to return to sport (months) among the three types of DM tear according to Ahn classification.Entire study duration (approximately 20 years)
Tegner activity level scale (0-10) among the three types of DM tear according to Ahn classification.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

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

Countries

Belgium, Finland, France, Italy, Portugal, Switzerland, United Kingdom

Contacts

Primary ContactMarco Turati, MD
marco.turati@unimib.it+39 0392333021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026