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

Cartilage Disease Clinical Trial

— HIP-ACTION  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179346
• Other study ID #: AAG-O-H-1304
• Status: Completed
• Start date: December 2014
• Est. completion date: June 18, 2018

Study information

• Verified date: December 2019
• Source: Tetec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 18, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Disease
• Cartilage Diseases

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav of TU Dresden	Dresden
Germany	Essen University Hospital	Essen
Germany	sporthopaedicum Straubing	Straubing

Sponsors (2)

Lead Sponsor	Collaborator
Tetec AG	Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life	Outcome of iHOT 33 as a measurement of function and Quality of life	12 and 24 months
Secondary	EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life	Outcome of EQ-5D-5L as a measurement of function and Quality of life	12 and 24 months