NL-OMON41021撤回不适用
Agili-C Implant Performance Evaluation in the Repair of Cartilage and OCD - Agili-C trial
Cartihael (2009) Ltd.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 18 to 55 years
- •2. Symptomatic, Painful, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral (grade 1,2,3,4A) isolated lesion of the femoral condyle, trochlea or the tibial plateau (limited to 4 millimeters in depth).
- •3. KOOS pain score is < 60 at baseline evaluation
- •4. Defect area is less than 3.5 cm². The defect is completely surrounded on all sides by healthy cartilage.
- •5. Primary or secondary articular cartilage repair.
- •6. Knee is stable or can be stabilized as a concomitant procedure.
- •7. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
- •8. Informed consent signing.
- •9. Any misalignments must be fully corrected at the end of the operative procedure.
排除标准
- •1. Uncorrected axial misalignments >5° that cannot be corrected.
- •2. Patellar cartilage defects or pathology.
- •3. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
- •4. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
- •5. Present or past acute or chronic infection of the treated knee.
- •6. Inflammatory arthropathy or crystal-deposition arthropathy.
- •7. Systemic cartilage and/or bone disorder; This implant's integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone
- •8. Bony defect depth over 4 millimeters.
- •9. Body mass index >35.
- •10. Asymptomatic articular cartilage defects.
- •11. Bipolar articular cartilage defects.
- •12. Osteoarthritis of the operated knee.
- •13. Oral medications such as systemic corticosteroid therapy taken less than one year prior to the surgery or chemotherapy.
- •14. Previous arthroscopic marrow stimulation or cell therapy within the last 6 months
- •15. Any previous cartilage treatment within the last 6 months
- •16. Patients who are sensitive to materials containing calcium carbonate or hyaluronate.
- •17. Pregnant women, Women of Childbearing Potential [WOCBP-defined as any female who has experienced menarche and does not meet the criteria for *Women Not of Childbearing Potential* which are: women who are postmenopausal,permanently sterilised (e.g. tubal ligation, hysterectomy, bilateral salpingectomy)], women who are not using a highly effective contraception method (as defined by ICH M3) during the entire duration of the clinical trial or breastfeeding women.
- •18. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the Subject's welfare.
- •19. Substance abuse or alcohol abuse.
- •20. Participation in other clinical trials in parallel to this study.
- •21. Type I diabetes.
- •22. Unable to undergo MRI or X-ray.
- •23. Any reasons making the Subject a poor candidate in the opinion of the investigator.
研究者
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