Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-05-31

Brief Summary

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Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.

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Detailed Description

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Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.

Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.

Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).

Conditions

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Cartilage Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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NOVOCART® Inject patients

Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* male and female patients
* juvenile patients with closed epiphysial plate
* insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
* defect size ≥ 2.5 and ≤ 10 cm2
* intact or reconstructed bony subchondral plate
* in the case of deep bony substance defects, additional bony reconstruction is needed

Exclusion Criteria

* radiographic signs of osteoarthritis of Kellgren and Lawrence \> 2
* joint stiffness
* arthrofibrosis
* malalignment in the knee (valgus- or varus deformity) \> 3° (correction contemporary to the ACT)
* insufficient reconstructed ligaments (correction contemporary to the ACT)
* defective position patella (correction contemporary to the ACT)
* sled prosthesis implants or carbon pin
* inflammatory joint diseases (f.e. rheumatoid arthritis)
* corresponding cartilage defects ("kissing lesions")
* more than two independent cartilage defects in one knee
* primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
* diffuse chondromalacia
* congenital or gained deformity of patella

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No