NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)

Aesculap

Status and phase: Active, not recruiting; Phase 3

Conditions: Articular Cartilage of the Femoral Condyle Between 2-6cm2

Treatments: Biological: NOVOCART 3D; Procedure: Microfracture

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957722

AAG-G-H-1220

Details and patient eligibility

About

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Full description

Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Enrollment: 233 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than 18 years old
• Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
• Minimum score on the KOOS questionnaire

Exclusion criteria

• Instability of the knee joint
• Arthritis
• Autoimmune disease
• Immune suppression
• Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
• Bone disease
• Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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233 participants in 2 patient groups

NOVOCART 3D

Experimental group

Description:

Scaffold assisted autologous chondrocyte Implant

Treatment:

Biological: NOVOCART 3D

Microfracture

Active Comparator group

Description:

considered a typical treatment for articular cartilage repair

Treatment:

Procedure: Microfracture