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

Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02941120

Acronym

RENOVO

Enrollment

245

Registered

2016-10-21

Start date

2015-12-31

Completion date

2019-05-31

Last updated

2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Disease

Keywords

Cartilage defect, Knee, ACT (Autologous chondrocyte implantation), NOVOCART® Inject

Brief summary

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

Detailed description

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse drug reaction/serious adverse drug reaction	Up to 24 months	Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety

Secondary

Measure	Time frame	Description
Outcome of IKDC 2000	Up to 24 months	Outcome of the IKDC 2000 as measurements of symptoms and function
Outcome of KOOS	Up to 24 months	Outcome of KOOS as measurements of symptoms and function

Countries

Germany

Outcome results