- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041885
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gent, Belgium
- University Hospital Gent
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Bydgoszcz, Poland
- University Hospital nber 2 Dr. Jana Biziela
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Katowice, Poland
- NZOZ "Szpital AVIMED" sp. z o.o.
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Poznan, Poland
- NZOZ Endomedical
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Warsaw, Poland
- Centrum Medycyny Sportowej (Sports Medicine Center CMS)
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Birmingham, United Kingdom
- Royal Orthopaedic Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: INSTRUCT
INSTRUCT scaffold implantation
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INSTRUCT PolyActive scaffold implantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of related adverse events
Time Frame: Over 24 months
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Over 24 months
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Lesion filling
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of non-related adverse events
Time Frame: 24 months
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24 months
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KOOS, IKDC and pain VAS scores
Time Frame: At all timepoints over 24 months
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At all timepoints over 24 months
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Histopathology assessments
Time Frame: 6 or 12 months
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6 or 12 months
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MRI evaluation of structural repair
Time Frame: Discharge, 3, 6, 12 and 24 months
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Discharge, 3, 6, 12 and 24 months
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dGEMRIC assessment of structural repair
Time Frame: 6, 12 and 24 months
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6, 12 and 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Joël Guidoux, CellCoTec B.V.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 309-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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