Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 8
- 主要终点
- • The KOOS Pain Subscale relative to baseline
研究概览
简要总结
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
详细描述
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
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
- •18 years or older
- •Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
- •Symptomatic total treatable area 1-7 cm
- •Asymptomatic lesions will not be included in the calculation
- •KOOS Pain score at baseline is not less than 30 and not more than 65
- •Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
- •Informed consent signing
排除标准
- •Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
- •Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
- •Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
- •Lack of functional remaining meniscus
- •Meniscal transplantation in the past 6 months
- •Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
- •Any known tumor of the index knee
- •Any know history of infection of the index knee
- •Any known history of inflammatory arthropathy or crystal-deposition arthropathy
- •Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
- •Body mass index >35
- •Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
- •Chemotherapy treatment in the past 12 months
- •Any previous surgical cartilage treatment in the index knee within the last 6 months
- •History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
- •Patient who is pregnant or intends to become pregnant during the study
- •History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
- •Known substance abuse or alcohol abuse
- •Participation in other clinical trials within 30 days prior to the study or concurrent with the study
- •Known insulin dependent diabetes mellitus
- •Unable to undergo MRI or X-ray
研究组 & 干预措施
Agili C™
Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.
干预措施: Agili-C™ implantation procedure (Device)
结局指标
主要结局
• The KOOS Pain Subscale relative to baseline
时间窗: 24 Months
The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m
次要结局
- • Improvement in other KOOS subscales relative to baseline(24 Months)
- • Improvement in IKDC Subjective Knee Score relative to baseline(24 Months)
- • Improvement in SF-36 Survey(24 Months)
- • Improvement in Tegner Score(24 Months)
- • Improvement in Lysholm Knee Scoring Scale(24 Months)
- • Joint Space maintenance rate according to X-ray(24 Months)
- • Defect Fill according to MRI(24 Months)
- Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline(24 mMonths)