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

Completed

• Conditions: Cartilage Disease

• Registration Number: NCT02179346
• Lead Sponsor: Tetec AG

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.

Study Timeline

• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Study Start: 2014-12
• Primary Completion: 2018-06
• Study Completion: 2018-06-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	24 months	Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.

Secondary Outcome Measures

Name	Time	Method
iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life	12 and 24 months	Outcome of iHOT 33 as a measurement of function and Quality of life
EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life	12 and 24 months	Outcome of EQ-5D-5L as a measurement of function and Quality of life

Trial Locations

Locations (3)

University Hospital Carl Gustav of TU Dresden; 🇩🇪 Dresden, Germany

sporthopaedicum Straubing; 🇩🇪 Straubing, Germany

Essen University Hospital; 🇩🇪 Essen, Germany