Case Series Study: Treatment of Osteochondral Defects in the Hip Using Microfracture Augmented with CelGro (Trademark) Collagen Matrix

Orthocell Ltd.0 个研究点目标入组 7 人开始时间: 2016年4月8日最近更新: 2022年10月31日

适应症

试验速览

暂无简介。

•Male or female between 18-55 years of age
•- Acetabular osteochondral defect (Outerbridge grade III or IV) measuring 2-8cm2
•- Radiologically confirmed Tonnis grade < 2
•- Able to comply with the requirements of the protocol, including post-treatment rehabilitation
•- Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP

•- Concomitant presence of femoral head chondral lesion (kissing lesion)
•- Rheumatoid arthritis
•- Dysplasia
•- Femoral neck axial deviation
•- Coxa profunda
•- Protrusio acetabuli
•- Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders
•- Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy
•- Female participant who is pregnant or lactating
•- Known substance abuse
•- Participation in another study with an investigational product within 3 months of visit 1
•- Concurrent medical condition which precludes the administration of study treatment
•- Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study

发起方