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

December 2, 2019 updated by: Tetec AG

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)

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

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Homburg, Germany, 61348
        • Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg
      • Gundelfingen, Germany, 79194
        • Gelenk-Klinik Gundelfingen
      • Kelkheim, Germany, 65779
        • Orthopädische Praxisklinik im Zentrum
      • Markgröningen, Germany, 71706
        • Orthopädische Klinik Markgröningen gGmbH
      • Münster, Germany, 48165
        • Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber
      • Sande, Germany, 26452
        • Nordwest-Krankenhaus Sanderbusch gGmbH
      • Wurzen, Germany, 04808
        • Muldentalkliniken GmbH Krankenhaus Wurzen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Orthopaedic clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tetec AG

Collaborators

Winicker Norimed GmbH
Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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