Skip to main content
OpenTrials
Completed

NCT Number: NCT01041885

INSTRUCT for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Articular Cartilage Lesion of the Knee

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Gent, Ghent, Belgium

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INSTRUCT

Device

INSTRUCT PolyActive scaffold implantation

Primary outcomes

  1. Incidence of related adverse events

    Time frame: Over 24 months

  2. Lesion filling

    Time frame: 3 months

Secondary outcomes

  1. Incidence of non-related adverse events

    Time frame: 24 months

  2. KOOS, IKDC and pain VAS scores

    Time frame: At all timepoints over 24 months

  3. Histopathology assessments

    Time frame: 6 or 12 months

  4. MRI evaluation of structural repair

    Time frame: Discharge, 3, 6, 12 and 24 months

  5. dGEMRIC assessment of structural repair

    Time frame: 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

CellCoTec B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jan 1, 2010
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.