Clinical trial NCT05580315: EPOS Discoid Meniscus (DiMe) Project
Official title: EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Discoid Meniscus of Knee
Keywords: discoid meniscus
knee
pediatric
sport medicine
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with symptomatic DM confirmed on the basis of physical examination and MRI

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
timeFrame: Enrollment period (approximately 5 years)
Secondary outcomes:
measure: Time to return to sport (months) among the three types of DM tear according to Ahn classification.
timeFrame: Entire study duration (approximately 20 years)
measure: Tegner activity level scale (0-10) among the three types of DM tear according to Ahn classification.
timeFrame: Entire study duration (approximately 20 years)
Other outcomes:
measure: Surgical treatment in each type of DM, according to Watanabe and Ahn classifications
timeFrame: Enrollment period (approximately 5 years)
measure: Pedi-IKDC related to anthropometric features and anamnestic characteristics.
timeFrame: Enrollment period (approximately 5 years)
measure: DM healing (timing of early phase, remodeling (high tissue enhancement), maturation measured in months from surgery - all measured with serial MRIs)
timeFrame: Entire study duration (approximately 20 years)
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis
city: Oulu
country: Finland
facility: Oulu University Hospital,
city: Grenoble
country: France
facility: CHU Grenoble
city: Toulouse
country: France
facility: Clinique Rive Gauche
city: Toulouse
country: France
facility: Department of Orthopaedic Surgery, Hôpital des Enfants, CHU de Toulouse
city: Bergamo
country: Italy
facility: Policlinico San Pietro
state: BG
city: Monza
country: Italy
facility: ASST Monza - Ospedale San Gerardo
city: Coimbra
country: Portugal
facility: Department of Pediatric Orthopaedics, Hospital Pediátrico de -Coimbra
city: Lisbona
country: Portugal
facility: Hospital Cuf Descobertas
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
city: London
country: United Kingdom
facility: London Children's Hospital
city: Sheffield
country: United Kingdom
facility: SHEFFIELD CHILDREN'S NHS NHS Foundation Trust,
Study officials:
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