EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •concomitant or previous knee surgeries
- •concomitant ligament knee injury that requires a surgical treatment
- •concomitant fractures
- •inflammatory or arthritic diseases.
结局指标
主要结局
Pedi-IKDC (0-100) among the three types of DM according to Ahn classification.
时间窗: Enrollment period (approximately 5 years)
次要结局
- 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))