Clinical trial NCT02941120: Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Disease
Keywords: Cartilage defect
Knee
ACT (Autologous chondrocyte implantation)
NOVOCART® Inject
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap AG
name: Winicker Norimed GmbH
First posted: 2016-10-21
Enrollment: 245
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic clinics

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse drug reaction/serious adverse drug reaction
timeFrame: Up to 24 months
Secondary outcomes:
measure: Outcome of IKDC 2000
timeFrame: Up to 24 months
measure: Outcome of KOOS
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg
city: Gundelfingen
country: Germany
facility: Gelenk-Klinik Gundelfingen
city: Kelkheim
country: Germany
facility: Orthopädische Praxisklinik im Zentrum
city: Markgröningen
country: Germany
facility: Orthopädische Klinik Markgröningen gGmbH
city: Münster
country: Germany
facility: Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber
city: Sande
country: Germany
facility: Nordwest-Krankenhaus Sanderbusch gGmbH
city: Wurzen
country: Germany
facility: Muldentalkliniken GmbH Krankenhaus Wurzen
Study officials:
References: