NCT06990100已完成不适用
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
SACIMEX2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年10月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- evaluate the performance of the DT4- EBMCA
研究概览
简要总结
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. This study evaluates its long-term performance and safety in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient implanted with DT4-EBMCA in Médipôle Garonne for a total or partial rupture of the anterior cruciate ligaments
- •Patient having answer to IKDC and KOOS pre-operative
- •Patient having received information and signed informed consent
排除标准
- •Patients who refuse to participate
- •Patients unable to understand questionnaires
- •Patients who, at the time of surgery, present the contraindications and Factors likely to jeopardize the success of the implant contained in the IFU :
- •Acute or chronic, local or systemic infections;
- •Severe muscular, neurological or vascular impairments affecting the extremity concerned;
- •Bone destruction or poor bone quality that may affect device stability;
- •Any concomitant condition that may affect device function;
- •Patients with sensitivity to device material that may cause allergic reactions.
- •Severe osteoporosis;
- •Significant deformity, congenital dislocation;
- •Local bone tumours;
- •Systemic or metabolic disorders;
- •Infectious diseases;
- •Substance abuse and/or tendencies to abuse drugs or medication;
- •Unsupervised intense physical activity.
研究组 & 干预措施
ACL rupture group
Other
Patients having a surgery with DT4-EBMCA medical device
干预措施: ACL surgery (Device)
结局指标
主要结局
evaluate the performance of the DT4- EBMCA
时间窗: 2 years post-surgery
International Knee Documentation Committee (IKDC) from the preoperative visit to the postoperative 2 years follow-up Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative visit to the postoperative 2 years follow-up
次要结局
- safety of of the DT4-EBMCA(2 years post-surgery)
研究者
研究点 (2)
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