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 - NOVOCART® 3D plus (N3D) Study

TETEC AG0 sites30 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: TETEC AG
Enrollment: 30
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

TETEC AG

Eligibility Criteria

Inclusion Criteria

•\*Patient is \* 18 and \* 65 year old at time of screening
•\*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 post\-debridement, 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..
•\* Patient has a defect size \* 2 and \* 6 cm2post\-debridement.
•\* Patient has an intact (\< Grade 2 ICRS classification) articulating joint surface (no \*kissing lesions\*).
•\* Patient has an intact meniscus (maximum 1/2\-resection).
•\*Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair has to be done within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•\*Patient has free range of motion of the affected knee joint or \*10 degrees of extension and flexion loss.
•\*Patient has a defect of grade III or IV according to the ICRS classification.
•\*Patient has a maximum baseline score of 60/100 on the 2000 IKDC subjective knee evaluation.
•\*Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow\-up visits and assessments and postoperative rehabilitation regimen.

Exclusion Criteria

•Only selected (preoperative) exclusion criteria have been listed below. For the complete list see protocol.
•Preoperative exclusion criteria:
•\* Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
•\* Patient is unable to undergo magnetic resonance imaging (MRI).
•\* Patient has prior surgical treatment of the target knee using mosaicplasty and/or microfracture (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable). Anterior cruciate ligament repair are accepted, if the target knee is stable or a primary ACL reconstruction is performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•\* Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade \> 2\.
•\* Patient has chronic inflammatory arthritis, and/or infectious arthritis.
•\* 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.
•\* Patient has an instable knee joint or unsufficiently reconstructed ligaments. If ligament repair is necessary, the repair has to be performed within 6 weeks to the planned cartilage treatment (ACT/microfracture).
•\* Patient has malalignment (no valgus\- or varus\-deformity) in the target knee. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in a.p. or rather p.a. projection.

Outcomes

Primary Outcomes

Not specified

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