Discoid Meniscus of KneeDiMeNCT05580315
EPOS Discoid Meniscus (DiMe) Project
An observational study of Discoid Meniscus of Knee, run by University of Milano Bicocca at 12 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Discoid Meniscus of Knee
- How many people
- 500 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 8 Sep 2022to 1 Sep 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with symptomatic DM confirmed on the basis of physical examination and MRI
Who may be able to join
- 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
Who cannot join
- concomitant or previous knee surgeries
- concomitant ligament knee injury that requires a surgical treatment
- concomitant fractures
- inflammatory or arthritic diseases.
Trial locations and contacts
12 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 7 countries
France3 sites, 3 recruiting
- Not yet recruiting
CHU Grenoble
Grenoble
Nicolas Bremond, nbremond@chu-grenoble.fr
- Not yet recruiting
Clinique Rive Gauche
Toulouse, 31076
Camille Thevenin-Lemoine, camille.theveninlemoine@gmail.com
- Not yet recruiting
Department of Orthopaedic Surgery, Hôpital des Enfants, CHU de Toulouse
Toulouse, 31300
Franck Accadbled, faccadbled@gmail.com
AURIOL Françoise, auriol.f@chu-toulouse.fr
Italy2 sites, 2 recruiting
- Not yet recruiting
Policlinico San Pietro
Bergamo, BG, 24036
Marco Bigoni, marco.bigoni@unimib.it
- Recruiting
ASST Monza - Ospedale San Gerardo
Monza, 20900
Marco Turati, marco.turati@unimib.it
Portugal2 sites, 2 recruiting
- Not yet recruiting
Department of Pediatric Orthopaedics, Hospital Pediátrico de -Coimbra
Coimbra
João Cabral, cabral.joao@gmail.com
- Not yet recruiting
Hospital Cuf Descobertas
Lisbon
Monika Thusing, thusingmonika@gmail.com
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
London Children's Hospital
London
Manoj Ramachandran, manojorthopod@gmail.com
- Not yet recruiting
SHEFFIELD CHILDREN'S NHS NHS Foundation Trust,
Sheffield
Nicolas Nicolaou, nicolas.nicolaou3@nhs.net
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitair Ziekenhuis
Leuven
Pieter Berger, pieterberger7@hotmail.com
Finland1 site, 1 recruiting
- Not yet recruiting
Oulu University Hospital,
Oulu
Sinikumpu Juha-Jaakko, jaakko.sinikumpu@gmail.com
Switzerland1 site, 1 recruiting
- Not yet recruiting
Centre hospitalier universitaire vaudois (CHUV)
Lausanne
Stephane Tercier, stephane.tercier@chuv.ch
About this study
Official title: EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol
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.
Read the 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.
- Conditions
- Discoid Meniscus of Knee
- Keywords
- discoid meniscus, knee, pediatric, sport medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
Measured: Enrollment period (approximately 5 years)
Secondary outcomes (2)
Time to return to sport (months) among the three types of DM tear according to Ahn classification.
Measured: Entire study duration (approximately 20 years)
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
Measured: Entire study duration (approximately 20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start8 Sep 2022
- Primary completion1 Sep 2042 (estimated)
- Study completion1 Sep 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Discoid Meniscus of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580315
- Sponsor's protocol ID
- DiMe
- Acronym
- DiMe
- Status last verified
- Jul 2025
- First submitted
- 4 Oct 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
Publications
Turati M, Anghilieri FM, Accadbled F, Piatti M, Di Benedetto P, Moltrasio F, Zatti G, Zanchi N, Bigoni M. Discoid meniscus in human fetuses: A systematic review. Knee. 2021 Jun;30:205-213. doi: 10.1016/j.knee.2021.04.006. Epub 2021 May 1.
PubMed 33945980Ahn JH, Lee SH, Yoo JC, Lee YS, Ha HC. Arthroscopic partial meniscectomy with repair of the peripheral tear for symptomatic discoid lateral meniscus in children: results of minimum 2 years of follow-up. Arthroscopy. 2008 Aug;24(8):888-98. doi: 10.1016/j.arthro.2008.03.002. Epub 2008 May 5.
PubMed 18657737Wasser L, Knorr J, Accadbled F, Abid A, Sales De Gauzy J. Arthroscopic treatment of discoid meniscus in children: clinical and MRI results. Orthop Traumatol Surg Res. 2011 May;97(3):297-303. doi: 10.1016/j.otsr.2010.11.009. Epub 2011 Mar 23.
PubMed 21435965Kinugasa K, Hamada M, Yonetani Y, Matsuo T, Mae T, Nakata K, Horibe S. Discoid lateral meniscal repair without saucerization for adolescents with peripheral longitudinal tear. Knee. 2019 Jun;26(3):803-808. doi: 10.1016/j.knee.2019.03.007. Epub 2019 May 7.
PubMed 31076246Matsuo T, Kinugasa K, Sakata K, Ohori T, Mae T, Hamada M. Post-operative deformation and extrusion of the discoid lateral meniscus following a partial meniscectomy with repair. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):390-396. doi: 10.1007/s00167-016-4393-6. Epub 2016 Dec 23.
PubMed 28012004Nepple JJ, Milewski MD, Shea KG. Research in Osteochondritis Dissecans of the Knee: 2016 Update. J Knee Surg. 2016 Oct;29(7):533-538. doi: 10.1055/s-0036-1586723. Epub 2016 Aug 17.
PubMed 27532280Moksnes H, Engebretsen L, Seil R. The ESSKA paediatric anterior cruciate ligament monitoring initiative. Knee Surg Sports Traumatol Arthrosc. 2016 Mar;24(3):680-7. doi: 10.1007/s00167-015-3746-x. Epub 2015 Aug 7.
PubMed 26249112Scott EJ, Westermann R, Glass NA, Hettrich C, Wolf BR, Bollier MJ. Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2018 May 25;6(5):2325967118774509. doi: 10.1177/2325967118774509. eCollection 2018 May.
PubMed 29854864Grant-Beuttler M, Jennings J, McCauley C, Dulay R, Grossnickle K, Kill K, Hay J. Development of an Electronic Version of The Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale. Pediatr Exerc Sci. 2017 Feb;29(1):153-160. doi: 10.1123/pes.2016-0115. Epub 2016 Oct 21.
PubMed 27768553Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.
PubMed 19261899Dietvorst M, Reijman M, van Groningen B, van der Steen MC, Janssen RPA. PROMs in paediatric knee ligament injury: use the Pedi-IKDC and avoid using adult PROMs. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1965-1973. doi: 10.1007/s00167-017-4687-3. Epub 2017 Sep 19.
PubMed 28929208Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8. doi: 10.1097/00003086-200108000-00002. No abstract available.
PubMed 11501822CholeS Study Group, West Midlands Research Collaborative. Population-based cohort study of outcomes following cholecystectomy for benign gallbladder diseases. Br J Surg. 2016 Nov;103(12):1704-1715. doi: 10.1002/bjs.10287. Epub 2016 Aug 26.
PubMed 27561954Courtney A, O'Connell R, Rattay T, Kim B, Cutress RI, Kirwan CC, Gandhi A, Fairbrother P, Sharma N, Cartlidge CWJ, Horgan K, McIntosh SA, Leff DR, Vidya R, Potter S, Holcombe C, Copson E, Coles CE, Dave RV. The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol. Int J Surg Protoc. 2020;24:1-5. doi: 10.1016/j.isjp.2020.07.003. Epub 2020 Jul 29.
PubMed 32838092
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol
- ClinicalTrials.gov ID
- NCT05580315
- Acronym / sponsor ID
- DiMe / DiMe
- Conditions
- Discoid Meniscus of Knee
- Keywords
- discoid meniscus, knee, pediatric, sport medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 1 Sep 2042 (estimated)
- Study completion
- 1 Sep 2042 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with symptomatic DM confirmed on the basis of physical examination and MRI
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- concomitant or previous knee surgeries
- concomitant ligament knee injury that requires a surgical treatment
- concomitant fractures
- inflammatory or arthritic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
Time frame: Enrollment period (approximately 5 years)
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 33945980Turati M, Anghilieri FM, Accadbled F, Piatti M, Di Benedetto P, Moltrasio F, Zatti G, Zanchi N, Bigoni M. Discoid meniscus in human fetuses: A systematic review. Knee. 2021 Jun;30:205-213. doi: 10.1016/j.knee.2021.04.006. Epub 2021 May 1.
- Background: PubMed 18657737Ahn JH, Lee SH, Yoo JC, Lee YS, Ha HC. Arthroscopic partial meniscectomy with repair of the peripheral tear for symptomatic discoid lateral meniscus in children: results of minimum 2 years of follow-up. Arthroscopy. 2008 Aug;24(8):888-98. doi: 10.1016/j.arthro.2008.03.002. Epub 2008 May 5.
- Background: PubMed 21435965Wasser L, Knorr J, Accadbled F, Abid A, Sales De Gauzy J. Arthroscopic treatment of discoid meniscus in children: clinical and MRI results. Orthop Traumatol Surg Res. 2011 May;97(3):297-303. doi: 10.1016/j.otsr.2010.11.009. Epub 2011 Mar 23.
- Background: PubMed 31076246Kinugasa K, Hamada M, Yonetani Y, Matsuo T, Mae T, Nakata K, Horibe S. Discoid lateral meniscal repair without saucerization for adolescents with peripheral longitudinal tear. Knee. 2019 Jun;26(3):803-808. doi: 10.1016/j.knee.2019.03.007. Epub 2019 May 7.
- Background: PubMed 28012004Matsuo T, Kinugasa K, Sakata K, Ohori T, Mae T, Hamada M. Post-operative deformation and extrusion of the discoid lateral meniscus following a partial meniscectomy with repair. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):390-396. doi: 10.1007/s00167-016-4393-6. Epub 2016 Dec 23.
- Background: PubMed 27532280Nepple JJ, Milewski MD, Shea KG. Research in Osteochondritis Dissecans of the Knee: 2016 Update. J Knee Surg. 2016 Oct;29(7):533-538. doi: 10.1055/s-0036-1586723. Epub 2016 Aug 17.
- Background: PubMed 26249112Moksnes H, Engebretsen L, Seil R. The ESSKA paediatric anterior cruciate ligament monitoring initiative. Knee Surg Sports Traumatol Arthrosc. 2016 Mar;24(3):680-7. doi: 10.1007/s00167-015-3746-x. Epub 2015 Aug 7.
- Background: PubMed 29854864Scott EJ, Westermann R, Glass NA, Hettrich C, Wolf BR, Bollier MJ. Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2018 May 25;6(5):2325967118774509. doi: 10.1177/2325967118774509. eCollection 2018 May.
- Background: PubMed 27768553Grant-Beuttler M, Jennings J, McCauley C, Dulay R, Grossnickle K, Kill K, Hay J. Development of an Electronic Version of The Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale. Pediatr Exerc Sci. 2017 Feb;29(1):153-160. doi: 10.1123/pes.2016-0115. Epub 2016 Oct 21.
- Background: PubMed 19261899Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.
- Background: PubMed 28929208Dietvorst M, Reijman M, van Groningen B, van der Steen MC, Janssen RPA. PROMs in paediatric knee ligament injury: use the Pedi-IKDC and avoid using adult PROMs. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1965-1973. doi: 10.1007/s00167-017-4687-3. Epub 2017 Sep 19.
- Background: PubMed 11501822Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8. doi: 10.1097/00003086-200108000-00002. No abstract available.
Related trials for Discoid Meniscus of Knee
Not yet recruiting
Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus
Discoid Meniscus of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discoid Meniscus of Knee, run by University of Milano Bicocca at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Italy, Portugal, United Kingdom, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Turati, MD (+39 0392333021, marco.turati@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification. (time frame: Enrollment period (approximately 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580315, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.