EPOS Discoid Meniscus (DiMe) Project
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 |
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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:
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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.
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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.
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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
Outcome Measures
Primary Outcome Measures
- Pedi-IKDC (0-100) among the three types of DM according to Ahn classification. [Enrollment period (approximately 5 years)]
Secondary Outcome Measures
- 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 Outcome Measures
- Surgical treatment in each type of DM, according to Watanabe and Ahn classifications [Enrollment 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
- 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
Inclusion Criteria:
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symptomatic DM confirmed by a senior orthopedic surgeon based on physical examination and MRI
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age less than eighteen years
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informed consent freely granted and acquired before the start of the study from legal representative
Exclusion Criteria:
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concomitant or previous knee surgeries
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concomitant ligament knee injury that requires a surgical treatment
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concomitant fractures
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inflammatory or arthritic diseases.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- Ahn 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.
- Briggs 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.
- CholeS 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. Erratum In: Br J Surg. 2018 Aug;105(9):1222.
- Courtney 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.
- Dietvorst 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.
- Grant-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.
- Kinugasa 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.
- Matsuo 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.
- Moksnes 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.
- Nepple 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. Erratum In: J Knee Surg. 2016 Nov;29(8):696.
- Outerbridge 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.
- Scott 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.
- 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.
- Wasser 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.
- DiMe