Cartilage Repair Study of Health Outcomes and Real-world Evidence (C-SHORE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months
研究概览
简要总结
This registry is designed to collect information on how different surgical procedures are used and how well they work in treating knee cartilage damage. Information will be collected from patients undergoing knee surgery for cartilage damage and entered into a large database that reflects routine clinical practice ("real-world" data). The data collected will be used to support future research and improve understanding of treatment outcomes for knee cartilage repair.
详细描述
The registry will collect both prospective and retrospective/prospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective Subjects
- •Provides written informed consent.
- •Is eighteen (18) years of age or older at time of consent and considered skeletally mature in the opinion of the investigator.
- •Scheduled to undergo knee cartilage surgery with the Marketed Product-MP01 OR other knee cartilage repair surgery.
- •For subjects having other knee cartilage repair surgery:
- •- Falls within Marketed Product-MP01 on label indication: Knee chondral or osteochondral lesions (ICRS grade III and above, 1-7cm2) in patients with or without mild-moderate knee osteoarthritis (K/L 0-3).
- •Has an electronic device and is willing and able to use the device to complete the 'Electronic Clinical Outcomes Assessment' (eCOA).
- •Willing and able to complete all requested questionnaires.
- •Able to follow instructions and deemed capable of completing registry protocol requirements.
- •Retrospective/Prospective Subjects
- •Provides written informed consent.
- •Was eighteen (18) years of age or older at time of surgery and considered skeletally mature at that time in the opinion of the investigator.
- •Underwent knee cartilage repair surgery with the Marketed Product-MP01 within the last 2-years.
- •Has an electronic device and is willing and able to use the device to complete the eCOA.
- •Willing and able to complete all requested questionnaires.
- •Able to follow instructions and deemed capable of completing registry protocol requirements.
- •Consents to retrospective data being collected from pre-operative visit(s) and surgery through to the point of consent as available in their medical notes.
排除标准
- •History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate/coral derivatives.
- •Is actively participating in a cartilage repair clinical trial.
- •For subjects having other knee cartilage repair surgery:
- •- Treatment will be on patellar lesion(s).
- •Has participated previously in this registry (with the index or contralateral knee).
- •Meets the definition of a Vulnerable Subject per ISO 14155 Section 3.56.
结局指标
主要结局
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months
时间窗: Baseline and 24 months
The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.
次要结局
未报告次要终点