full-thickness traumatic or degenerative cartilage defects on femorale condyles of the knee joint M17 M94.86
Conditions
Interventions
Group 1: microfracture (Arthroscopy or Arthrotomy)
Group 2: microfracture in combination with chondrotissue® (Arthroscopy or Arthrotomy)
Sponsors
BioTissue AG
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| defect filling 12 weeks after microfracture and chondrotissue® treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Microfracture treatment with chondrotissue® implantation leads to better cartilage tissue formation than arthroscopic microfracture treatment without chondrotissue® implantation after 12 weeks as assessed by MRI. In addition, the secondary objective is to evaluate the long-term effects of the implantation of chondrotissue® by showing that arthroscopic microfracture treatment with the implantation of chondrotissue® leads to better cartilage tissue formation after 54, and 108 weeks as assessed by magnetic resonance imaging (MRI) than arthroscopic microfracture treatment without chondrotissue® implantation. Furthermore, the secondary objective is to show that the clinical results after implantation of chondrotissue® are better than microfracture treatment as assessed by patient questionnaires (ICRS, KOOS, VAS pain, Tegner score, SF-36) after 12, 54 and 108 weeks. As a safety objective, the side effects and postoperative morbidity (swelling, haemarthrosis) after microfracture treatment with or without the application of chondrotissue® will be compared. | — |
Countries
Belgium, Germany, Italy, Switzerland
Contacts
Public ContactSebastian Schröder
BioTissue AG
Outcome results
None listed