Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

PHASE3CompletedINTERVENTIONAL
Enrollment

263

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

March 6, 2020

Study Completion Date

February 28, 2023

Conditions
Traumatic Articular Cartilage Defects in the Knee Joint
Interventions
DRUG

NOVOCART® 3D plus

Two-Step intervention: 1) cartilage cells are collected from the patient during arthroscopy 2) collected cartilage cells are cultivated in a sterile environment, seeded in an organic matrix scaffold and implanted into the defect location (knee, femur)

PROCEDURE

Microfracture

single-step treatment: defect location (knee, femur) is debrided, then bone plate is drilled mechanically to allow cells from the bone marrow to move to the defect location and to develop a scar tissue

Trial Locations (35)

1005

Hospital of Traumatology and Orthopaedics, Trauma Department, Riga

Orto Clinic, Riga

1145

Uzsoki utcai Kórház, Budapest

1190

Privatklinik Doebling, Vienna

2890

Kastélypark Klinika, Tata

3526

B-A-Z Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc

4031

Universitätsklinikum Basel, Basel

9024

Petz Aladár Megyei Oktató Kórház, Győr

9700

Markusovszky Egyetemi Oktatókórház, Szombathely

10318

"JSC SK Impeks Medicinos Diagnostikos Centras", Vilnius

15006

Fakultni nemocnice v Motole, Prague

16902

UVN - Vojenska fakultni nemocnice Praha, Prague

26831

NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice, Hořovice

34075

Polyclinique Saint-Roch, Montpellier

40611

Szpital Angelius, Katowice

41940

Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej, Piekary Śląskie

42200

Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego, Częstochowa

42270

CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie, Saint-Priest-en-Jarez

43309

Szpital sw. Lukasza BGL Sp z o.o. S.K.A., Bielsko-Biala

44320

Kaunas clinical hospital, Kaunas

50005

Fakultni nemocnice Hradec Kralove - Ortopedicka klinika, Hradec Králové

50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

53203

Pardubicka nemocnice, Pardubice

62500

Fakultni nemocnice Brno - Ortopedicka klinika, Brno

66250

Urazova nemocnice v Brne - Traumatologie, Brno

68165

Theresienkrankenhaus, Mannheim

75005

Clinique V - Clinique du Sport, Paris

79106

Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie, Freiburg im Breisgau

81377

Orthopädische Klinik und Poliklinik der LMU München, München

92104

Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie, Boulogne-Billancourt

92288

Klaipeda university hospital, Klaipėda

93042

Universitätsklinikum Regensburg, Regensburg

05263

"JSC Kardiolita", Vilnius

02034

Centrum Medycyny Sportowej, Warsaw

EX2 5DW

Royal Devon and Exeter Hospital, Exeter

All Listed Sponsors
lead

Tetec AG

INDUSTRY

NCT01656902 - Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects | Biotech Hunter | Biotech Hunter