Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
This trial is active, not recruiting.
|Start date||December 2014|
|End date||December 2017|
|Trial size||21 participants|
|Trial identifier||NCT02179346, AAG-O-H-1304|
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Dresden, Germany||University Hospital Carl Gustav of TU Dresden||no longer recruiting|
|Essen, Germany||Essen University Hospital||no longer recruiting|
|Straubing, Germany||sporthopaedicum Straubing||no longer recruiting|
NOVOCART® Inject Autologous Chondrocyte Implantation
time frame: 12 months
time frame: 12 months
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - Male and female patients between 18 and 60 years - Insulated full thickness cartilage damage of the hip joint after ICRS grade 3 - Received subchondral bone lamella - received or reconstructed labrum in labrum cartilage defects - defect size ≥ 1.5 and ≤ 10 cm2 - Intact surrounding cartilage structure around the defect, and the corresponding articular surface - existence of the written informed consent of the patients after Enlightenment Exclusion Criteria: - More than 2 defects or 2 corresponding defects - defects in both lower extremities simultaneously - Radiographic signs of osteoarthritis of Kellgren & Lawrence > 1 - Profound bony lesion > 0.5 cm in the defect area - Presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases - Skin injury to the limb to be operated on - cartilage defect of the corresponding articular surface - Existing medications, drugs or alcohol - Acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases - impairment of the upper extremity, which prevents discharge by Crutches - Known bleeding disorder, such as Hemophilia A / B or thrombophilia - pregnancy and lactation, which represent the time of treatment is a contraindication - Known allergy to the ingredients - inmates in prisons
|Official title||Observational Study on the Feasibility, Safety and Efficacy in the Biological Reconstruction of the Hip Joint With Full Thickness Cartilage Defects With an in Situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)|
|Principal investigator||Klaus-Peter Guenther, Prof. MD|
|Description||Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip. Safety: 12-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions. Efficacy: 12-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.|
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