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
- Conditions
- full-thickness traumatic or degenerative cartilage defects on femorale condyles of the knee jointM17M94.86Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00016701
- Lead Sponsor
- BioTissue AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
• 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
• 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
• Laxity
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method defect filling 12 weeks after microfracture and chondrotissue® treatment
- Secondary Outcome Measures
Name Time Method