EPOS Discoid Meniscus (DiMe) Project
ConditionDiscoid Meniscus of Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
concomitant or previous knee surgeries
concomitant ligament knee injury that requires a surgical treatment
concomitant fractures
inflammatory or arthritic diseases.
Trial population
Children diagnosed with symptomatic DM confirmed on the basis of physical examination and MRI
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Tegner activity level scale:0=Sick leave or disability pension because of knee problems 10=Competitive sports Soccer - national and international elite
Time frame
Entire study duration (approximately 20 years)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.
The Pediatric International Knee Documentation Committee (Pedi-IKDC) Subjective Knee Evaluation Form
Time frame
Enrollment period (approximately 5 years)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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov