This trial is active, not recruiting.

Condition cartilage disease
Sponsor Tetec AG
Collaborator Aesculap AG
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

Study Design

Observational model case-only
Time perspective prospective
NOVOCART® Inject Autologous Chondrocyte Implantation

Primary Outcomes

time frame: 12 months

Secondary Outcomes

time frame: 12 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Tetec AG.