Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02179346
• Date of registration: 27/06/2014
• Prospective Registration: Yes
• Primary sponsor: Tetec AG
• Public title: Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects HIP-ACTION
• Scientific 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)
• Date of first enrolment: December 2014
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02179346
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Klaus-Peter Guenther, Prof. MD
• Affiliation: Universitätsklinikum Carls Gustav Carus der TU Dresden

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cartilage Disease

Primary Outcome(s)

Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety. [Time Frame: 24 months]

Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety. [Time Frame: 12 months]

Secondary Outcome(s)

EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life [Time Frame: 12 and 24 months]

iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life [Time Frame: 12 and 24 months]

Secondary ID(s)

AAG-O-H-1304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aesculap AG