DRKS00016701已完成3 期
A Randomized Open-Label Study on Safety and Efficacy of Chondrotissue® in Microfracture Treatment of Local Femoral Cartilage Defects in the Knee - chondrotissue® in microfracture treatment
BioTissue AG0 个研究点目标入组 30 人开始时间: 2019年2月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Local femoral defect at the knee joint
- •Cartilage defect size: 1 – 4 cm2
- •Patients between 18 and 60 years of age at the time of surgery
- •Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical evaluations/visits
- •Patients who have signed the Ethics Committee-approved Informed Consent Form prior to surgery
- •Indications for microfractures:
- •- focal and contained lesions, typically less than 2 to 4 cm² in size
- •- full-thickness loss of articular cartilage in weight-bearing areas
- •- unstable cartilage covering the underlying intact subchondral bone
- •- degenerative changes in a knee that is normally aligned
排除标准
- •Known allergic reactions to PGA or Hyaluronan
- •Chemotherapy or radiotherapy up to three weeks after implantation
- •Defect of the femoropatellar joint
- •Varus and valgus (more than 5°) (30 cm one leg standing apical X-ray)
- •General osteoarthritis (two or more compartments)
- •Rheumatoid arthritis or Bechterew’s disease
- •Joint stiffness (flexion less than 90°)
- •Obesity > 30 BMI
- •Tibial defect > 2 Outerbridge classification
- •Meniscus lesions with more than 1/3 partial resection
- •History with previous cartilage surgery (osteochondral transplantation (OCT), autologous chondrocyte transplantation (ACT))
- •History with previous microfracture in the symptomatic defect less than 6 month
- •History with previous knee surgery (anterior crucial ligament, meniscus refixation, osteotomy) less than 6 month
- •Meniscus lesions adjacent to the symptomatic cartilage defect
- •Osteochondral defects
- •Pregnancy and breastfeeding
研究者
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