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

NCT ID: NCT02179346

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-06-18

Brief Summary

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

Detailed 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.

Conditions

Cartilage Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cartilage defects in the hip joint

NOVOCART® Inject Autologous Chondrocyte Implantation

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: collaborator

Tetec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus-Peter Guenther, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Carls Gustav Carus der TU Dresden

Locations

University Hospital Carl Gustav of TU Dresden

Dresden, , Germany

Essen University Hospital

Essen, , Germany

sporthopaedicum Straubing

Straubing, , Germany

Countries

Germany

Other Identifiers

AAG-O-H-1304

Identifier Type: -

Identifier Source: org_study_id