INSTRUCT for Repair of Knee Cartilage Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Articular Cartilage Lesion of the Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INSTRUCT

INSTRUCT scaffold implantation

Group Type EXPERIMENTAL

INSTRUCT

Intervention Type DEVICE

INSTRUCT PolyActive scaffold implantation

Interventions

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INSTRUCT

INSTRUCT PolyActive scaffold implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No