A Retrospective, Observational, Post-market Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Assessment of total SEFAS (self-reported foot and ankle score) outcome
研究概览
简要总结
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects.
The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).
详细描述
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal OCDs. The overall clinical investigation is based on the patient's reported outcome (PROs) from OCD patients previously treated with Episealer Talus implant after January 2020. In total approximately 25 adult subjects, male or female, from 6 clinics (Sweden and Germany) will be included in the investigation.
Subjects will be identified by the investigational site team through medical record review and/or site knowing the subjects from performing the implantation after January 2020. Following collection of the subject´s signed informed consent, subject demographics, health- and surgery-related data will be collected from the subjects' medical records. Therefore, only one visit is planned for each subject during the clinical investigation. The performance variables relate to quality of life, and all subjects will be asked to fill in three questionnaires (SEFAS, FAOS and VAS).
The overall duration of the investigation is estimated to be 4 months, including a 1 month recruitment period. Each subject is estimated to spend approximately 1-2 hour for completing the informed consent and completing the questionnaires. Subject´s participation in the clinical investigation will be terminated once the questionnaires have been completed and the site team considers all data collected for the subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Patients ≥ 18 years old at the time of index procedure
- •Patients who previously received Episealer Talus implant after January 2020
排除标准
- 未提供
结局指标
主要结局
Assessment of total SEFAS (self-reported foot and ankle score) outcome
时间窗: 1 hour
SEFAS data will be extracted from the patient´s reported outcome (PROs). Range 0-48, low score is better
次要结局
- Assessment of total FAOS (Foot and Ankle Outcome Score) and subscale (pain, other symptoms, activities of daily living, sport and recreational function,(30 minutes)
- Additional clinical performance parameters of Episealer Talus implant(10 minutes)
- Assessment of total Visual Analogue Scale and subsections (rest, walking running, climb steps)(10 minutes)
- Surgery-related information(10 minutes)