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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Incidence of related adverse events [ Time Frame: Over 24 months ] [ Designated as safety issue: Yes ]
- Lesion filling [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of non-related adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- KOOS, IKDC and pain VAS scores [ Time Frame: At all timepoints over 24 months ] [ Designated as safety issue: No ]
- Histopathology assessments [ Time Frame: 6 or 12 months ] [ Designated as safety issue: No ]
- MRI evaluation of structural repair [ Time Frame: Discharge, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
- dGEMRIC assessment of structural repair [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
INSTRUCT scaffold implantation
INSTRUCT PolyActive scaffold implantation
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041885
|University Hospital Gent|
|University Hospital nber 2 Dr. Jana Biziela|
|NZOZ "Szpital AVIMED" sp. z o.o.|
|Centrum Medycyny Sportowej (Sports Medicine Center CMS)|
|Royal Orthopaedic Hospital|
|Birmingham, United Kingdom|
|Study Director:||Joël Guidoux||CellCoTec B.V.|