Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects (HIP-ACTION)

Tissue Engineering Technologies (TETEC)

Status: Completed

Conditions: Cartilage Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02179346

AAG-O-H-1304

Details and patient eligibility

About

Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.

Full description

Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.

Safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.

Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.

Enrollment: 21 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Cartilage defects in the hip joint

Description:

NOVOCART® Inject Autologous Chondrocyte Implantation