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Completed

NCT Number: NCT02941120

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

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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Key information

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg, Bad Homburg, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of adverse drug reaction/serious adverse drug reaction

    Time frame: Up to 24 months

    Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety

Secondary outcomes

  1. Outcome of IKDC 2000

    Time frame: Up to 24 months

    Outcome of the IKDC 2000 as measurements of symptoms and function

  2. Outcome of KOOS

    Time frame: Up to 24 months

    Outcome of KOOS as measurements of symptoms and function

Sponsors and collaborators

Lead sponsor

Tetec AG

Industry

Collaborators

  • Aesculap AG
  • Winicker Norimed GmbH

Registry information

Official study title

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)

Acronym: RENOVO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2016
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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