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INSTRUCT for Repair of Knee Cartilage Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01041885
Recruitment Status : Completed
First Posted : January 1, 2010
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
CellCoTec B.V.

Brief Summary:
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.

Condition or disease Intervention/treatment
Articular Cartilage Lesion of the Knee Device: INSTRUCT

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
Study Start Date : January 2010
Primary Completion Date : September 2012
Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: INSTRUCT
INSTRUCT scaffold implantation
Device: INSTRUCT
INSTRUCT PolyActive scaffold implantation



Primary Outcome Measures :
  1. Incidence of related adverse events [ Time Frame: Over 24 months ]
  2. Lesion filling [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041885


Locations
Belgium
University Hospital Gent
Gent, Belgium
Poland
University Hospital nber 2 Dr. Jana Biziela
Bydgoszcz, Poland
NZOZ "Szpital AVIMED" sp. z o.o.
Katowice, Poland
NZOZ Endomedical
Poznan, Poland
Centrum Medycyny Sportowej (Sports Medicine Center CMS)
Warsaw, Poland
United Kingdom
Royal Orthopaedic Hospital
Birmingham, United Kingdom
Sponsors and Collaborators
CellCoTec B.V.
Investigators
Study Director: Joël Guidoux CellCoTec B.V.

Responsible Party: CellCoTec B.V.
ClinicalTrials.gov Identifier: NCT01041885     History of Changes
Other Study ID Numbers: 309-019
First Posted: January 1, 2010    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by CellCoTec B.V.:
knee cartilage defect repair
cartilage lesion
autologous chondrocyte
scaffold
INSTRUCT