Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA) Enrolled in the Clinical Study CTD-SW CR500™-KOA 2020
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Lequesne Knee Index (LKI) Score
研究概览
简要总结
Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.
详细描述
To assess whether and when the patients enrolled in the CTD-SW CR500™-KOA 2020 clinical study required new orthopaedic treatment for knee osteoarthritis, starting at least 24 months after the conclusion of the clinical study.
Evaluate whether, in the long term, despite the potential bias of other therapies, treatment with CR500 has led to a lasting improvement, especially in comparison with infiltrative treatments based on the literature.
Collect data on patient satisfaction with the therapy received
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Oral informed consent from the patient.
- •Participation in the CTD-SW CR500™-KOA 2020 clinical study.
- •Willingness to participate in the survey.
排除标准
- •Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study
研究组 & 干预措施
CR500 single-dose gel
This retrospective phone follow-up involves the 35 patients who completed the CTD-SW CR500™-KOA 2020 study. After obtaining consent, patients will be asked whether and when they required further therapeutic interventions for KOA after the trial. This information will describe the long-term course of each arm by identifying subsequent treatments needed beyond the interventions originally administered during the study.
干预措施: CR 500™ SINGLE-DOSE GEL (Device)
结局指标
主要结局
Lequesne Knee Index (LKI) Score
时间窗: At least after 24 Months from the end of NCT05661162 study visit
The primary efficacy endpoint of the study will be the evaluation of the long-term clinical performance of the CR500™, used as intended in patients affected by KOA, in variation of symptoms related to the physiological degeneration of cartilage typical of osteoarthritic processes, in terms of difference in LKI score between the end of NCT05661162 study visit and follow-up visit. Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA
次要结局
- Need for additional therapies before and after CR500™.(At least after 24 Months from the end of NCT05661162 study visit.)
- Timing and type of other interventions performed on the same knee with KOA treated with CR500™ in the NCT05661162 study.(At least after 24 Months from the end of NCT05661162 study visit)
- Long-term satisfaction with the CR500™ treatment.(At least after 24 Months from the end of NCT05661162 study visit)
- Recurrence of pain in the CR500™-treated knee and prosthesis status.(At least after 24 Months from the end of NCT05661162 study visit)