Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Rate of Implant Failure
研究概览
简要总结
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
详细描述
BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.
The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Pre-procedure KOOS Pain subscale score less than or equal to
- •ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter.
- •Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft.
排除标准
- •Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended implantation site.
- •Clinically significant (> 5 degrees) varus or valgus malalignment in either knee.
- •Osteoarthritis in the injured knee.
- •Inflammatory arthropathy
- •Osteomyelitis or other active infection in either lower limb.
- •Cortisone or hyaluronic acid knee injections in the past 3 months
- •Body mass index greater than 35.
结局指标
主要结局
Rate of Implant Failure
时间窗: 24 months
Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication
次要结局
- Knee Related Adverse Events(24 months)
- Quality of repair tissue as assessed by magnetic resonance imaging(at 24 months)
- Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire(24 months)