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

NCT02179346 | Completed

• 1 other identifier: AAG-O-H-1304
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cartilage Disease

Keywords

cartilage defect; hip; impingement

Outcome Measures

Primary Outcomes (2)

• Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

  Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

  12 months

• Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

  Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

  24 months

Secondary Outcomes (2)

• iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life

  12 and 24 months

• EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life

  12 and 24 months

Study Arms (1)

Cartilage defects in the hip joint

NOVOCART® Inject Autologous Chondrocyte Implantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

specialist clinical centre

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tetec AG: lead
• Aesculap AG: collaborator

Study Sites (3)

University Hospital Carl Gustav of TU Dresden

Dresden, 01307, Germany

Location

Essen University Hospital

Essen, 45147, Germany

Location

sporthopaedicum Straubing

Straubing, 94315, Germany

Location

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Klaus-Peter Guenther, Prof. MD

  Universitätsklinikum Carls Gustav Carus der TU Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 18, 2018
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)