RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee (TIGACT01)
Articular Cartilage Lesion of the Femoral Condyle
Drug: ChondroCelect implantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||February 2002|
|Study Completion Date:||January 2010|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|