Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects (NCT02941120) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Germany245 participantsStarted 2015-12
Plain-language summary
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
Who can participate
Age range14 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* male and female patients
* juvenile patients with closed epiphysial plate
* insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
* defect size ≥ 2.5 and ≤ 10 cm2
* intact or reconstructed bony subchondral plate
* in the case of deep bony substance defects, additional bony reconstruction is needed
Exclusion Criteria:
* radiographic signs of osteoarthritis of Kellgren and Lawrence \> 2
* joint stiffness
* arthrofibrosis
* malalignment in the knee (valgus- or varus deformity) \> 3° (correction contemporary to the ACT)
* insufficient reconstructed ligaments (correction contemporary to the ACT)
* defective position patella (correction contemporary to the ACT)
* sled prosthesis implants or carbon pin
* inflammatory joint diseases (f.e. rheumatoid arthritis)
* corresponding cartilage defects ("kissing lesions")
* more than two independent cartilage defects in one knee
* primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
* diffuse chondromalacia
* congenital or gained deformity of patella
What they're measuring
1
Number of adverse drug reaction/serious adverse drug reaction