EPOS Discoid Meniscus (DiMe) Project

Sponsor
University of Milano Bicocca (Other)
Overall Status
Recruiting
CT.gov ID
NCT05580315
Collaborator
(none)
500
12
239.8
41.7
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol
    Actual Study Start Date :
    Sep 8, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2042
    Anticipated Study Completion Date :
    Sep 1, 2042

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Time to return to sport (months) among the three types of DM tear according to Ahn classification. [Entire study duration (approximately 20 years)]

    2. 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 Outcome Measures

    1. Surgical treatment in each type of DM, according to Watanabe and Ahn classifications [Enrollment period (approximately 5 years)]

    2. 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

    3. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitair Ziekenhuis Leuven Belgium
    2 Oulu University Hospital, Oulu Finland
    3 CHU Grenoble Grenoble France
    4 Clinique Rive Gauche Toulouse France 31076
    5 Department of Orthopaedic Surgery, Hôpital des Enfants, CHU de Toulouse Toulouse France 31300
    6 Policlinico San Pietro Bergamo BG Italy 24036
    7 ASST Monza - Ospedale San Gerardo Monza Italy 20900
    8 Department of Pediatric Orthopaedics, Hospital Pediátrico de -Coimbra Coimbra Portugal
    9 Hospital Cuf Descobertas Lisbona Portugal
    10 Centre hospitalier universitaire vaudois (CHUV) Lausanne Switzerland
    11 London Children's Hospital London United Kingdom
    12 SHEFFIELD CHILDREN'S NHS NHS Foundation Trust, Sheffield United Kingdom

    Sponsors and Collaborators

    • University of Milano Bicocca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Milano Bicocca
    ClinicalTrials.gov Identifier:
    NCT05580315
    Other Study ID Numbers:
    • DiMe
    First Posted:
    Oct 14, 2022
    Last Update Posted:
    Oct 14, 2022
    Last Verified:
    Sep 1, 2022
    Keywords provided by University of Milano Bicocca

    Study Results

    No Results Posted as of Oct 14, 2022