A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee.

TETEC – Tissue Engineering Technologies – AG0 sites261 target enrollmentOctober 21, 2014

ConditionsRepair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral or trochlea) of 2-6cm².MedDRA version: 20.0Level: PTClassification code 10052913Term: Cartilage operationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: LLTClassification code 10007705Term: Cartilage damageSystem Organ Class: 100000004863 MedDRA version: 20.0Level: LLTClassification code 10057104Term: Cartilage repairSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0Level: PTClassification code 10064112Term: Cartilage graftSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Repair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral or trochlea) of 2-6cm².
Sponsor: TETEC – Tissue Engineering Technologies – AG
Enrollment: 261
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 21, 2014

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

TETEC – Tissue Engineering Technologies – AG

Eligibility Criteria

Inclusion Criteria

•Pre\-operative inclusion criteria:
•At visit 1 patients must meet the following inclusion criteria for enrollment; all criteria must be answered with yes” before the patient is scheduled for arthroscopy:
•1\. Patient is \= 18 and \= 65 years old at screening or (in selected
•countries only) is a pediatric patient (14 to 17 years old) with closed
•epiphyseal growth plate (confirmation of closure of the epiphyseal
•growth plate of the index knee by X\-ray or MRI required).
•2\. Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is \= 6 cm2 and the size of each individual lesion is \= 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART® 3D plus or microfracture.
•3\. Patient has a defect size \= 2 and \= 6 cm2\. Note: defect size can be estimated by MRI at visit 1 if no data is available from medical history.
•4\. Patient has an intact articulating joint surface (\= Grade 2 International Cartilage Repair Society \[ICRS] classification, no kissing lesions”). Note: ICRS classification can be estimated by MRI at visit 1 if no data is available from medical history.
•5\. Patient has an intact meniscus; a maximum of 50% resection is allowed. Note: status of meniscus can be estimated at visit 1 if no data is available from medical history.

Exclusion Criteria

•Pre\-operative exclusion criteria:
•At visit 1 none of the following exclusion criteria must apply to any enrolled patient; all criteria must be answered with no” before the patient is scheduled for arthroscopy:
•1\. Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
•2\. Patient is unable to undergo magnetic resonance imaging (MRI).
•3\. Patient has prior surgical treatment of the target knee using mosaicplasty, autologous chondrocyte transplantation and/or microfracture. Note: prior diagnostic arthroscopies with debridement and lavage are acceptable. Ligament repair is accepted, if performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
•4\. Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade \= 2 (see Appendix A).
•5\. Patient has chronic inflammatory arthritis and/or infectious arthritis.
•6\. Patient has joint space narrowing \> 1/3 in the target knee when compared to the other knee or \< 3 mm joint space measured on x\-ray.
•7\. Patient has malalignment (valgus\- or varus\-deformity) in the target knee. Note: In suspected cases, the mechanical axis must be established radiographically by complete leg imaging in standing position and in a.p. or rather p.a. projection. The Mikulicz line is not allowed to deviate more than 5 mm of the eminentia intercondylaris. If alignment is necessary, surgery has to be performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
•8\. Patient has prior surgical treatment of clinical relevance of the target knee.