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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Cartilage Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cartilage defects in the hip joint<br>NOVOCART® Inject Autologous Chondrocyte Implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, cartilage defect, impingement