INSTRUCT for Repair of Knee Cartilage Defects

Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects

The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.

This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.

All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.

Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).

Inclusion Criteria:

• Patients with a symptomatic articular cartilage defect in the knee

Exclusion Criteria:

• Surgery on the study knee joint within 6 months
• Patients with significant malalignment (more than 5°)
• Patients with ligamentous instability of the knee
• Majority of the meniscus absent
• Severe osteoarthritis
• Intake of medications or treatments having an effect on bone or cartilage formation