INSTRUCT for Repair of Knee Cartilage Defects

CellCoTec

Status: Completed

Conditions: Articular Cartilage Lesion of the Knee

Treatments: Device: INSTRUCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01041885

309-019

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

INSTRUCT

Experimental group

Description:

INSTRUCT scaffold implantation

Treatment:

Device: INSTRUCT