RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee (TIGACT01)
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|ClinicalTrials.gov Identifier: NCT00414700|
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : January 18, 2010
Last Update Posted : September 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Articular Cartilage Lesion of the Femoral Condyle||Drug: ChondroCelect implantation Procedure: Microfracture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Multicenter Randomized Controlled Trial of ChondroCelect® (Via Autologous Chondrocyte Implantation) vs Microfracture (as Procedure) in the Repair of Symptomatic Cartilaginous Defects of the Femoral Condyles|
|Study Start Date :||February 2002|
|Primary Completion Date :||July 2006|
|Study Completion Date :||January 2010|
Drug: ChondroCelect implantation
10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.
The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm².
Other Name: CCI
|Active Comparator: Microfracture||
A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.
Other Name: subchondral drilling
- Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining [ Time Frame: 12 months post-surgery ]Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.
- Overall Histology Assessment on First Subscale of ICRS II Score [ Time Frame: 12 months post-surgery ]Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)
- Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average) [ Time Frame: Average change from baseline in Overall KOOS at 12-18 months post-surgery ]Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.
- Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months [ Time Frame: Change from baseline in Overall KOOS at 36 months post-surgery ]Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.
- Number of Treatment Failures at 36 Months [ Time Frame: Continuous ]
Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.
The index lesion is the lesion that was initially treated in the study.
- Safety: Adverse Events [ Time Frame: continuous up to 60 months ]Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).
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): NCT00414700
|AZ St. Jan Brugge, Department of Orthopedics|
|Brugge, Belgium, 8000|
|AZ St Lucas Brugge, Department of Orthopedics|
|Brugge, Belgium, 8310|
|Academisch Ziekenhuis, Vrije Universiteit Brussel, Department of Orthopedics|
|Brussels, Belgium, 1090|
|SPM Monica Antwerp|
|Deurne, Belgium, 2100|
|Ghent University Hospital, Department of Orthopedics|
|Ghent, Belgium, 9000|
|AZ St. Elisabeth, Department of Orthopedics|
|Herentals, Belgium, 2200|
|AZ Groeninge, Department of Orthopedics|
|Kortrijk, Belgium, 8500|
|University Hospitals Leuven, Department of Orthopedics|
|Leuven, Belgium, 3000|
|A.Z. Sint Jozef, Department of Orthopedics|
|Malle, Belgium, 2390|
|Department of Orthopedic Surgery, School of Medicine, University of Zagreb|
|Zagreb, Croatia, 10000|
|University Hospital Hannover, Department of Orthopedics|
|Hannover, Germany, 30625|
|University Medical Center Utrecht, Department of Orthopedics|
|Utrecht, Netherlands, 3584|
|Principal Investigator:||Daniël BF Saris, M.D., Ph.D.||University Medical Center Utrecht, Department of Orthopedics, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.|
|Principal Investigator:||Johan Vanlauwe, M.D.||University Hospitals Leuven, Department of Orthopedics, Herestraat 49, 3000 Leuven, Weligerveld 1, 3212 Pellenberg, Belgium.|
|Study Director:||Frank P Luyten, M.D., Ph.D.||Division of Rheumatology, Department of Muskuloskeletal Sciences, University Hospitals, Katholieke Universiteit Leuven, Herestraat 49, 3000 Leuven, Belgium|