At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
autologous cultured chondrocytes on porcine collagen membrane +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.
In Brief
A Phase 3 clinical trial evaluating autologous cultured chondrocytes on porcine collagen membrane and Microfracture for Articular Cartilage Defect. Completed, enrolled 144 participants across 20 sites in 7 countries.
Detailed Summary
The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArticular Cartilage Defect
CountriesCzechia, France, Netherlands, Norway, Poland, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionMar 2012
TodayJul 2026
First PostedJul 21, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.9 years ago
Interventions
autologous cultured chondrocytes on porcine collagen membranebiological
Implantation via mini-arthrotomy
Microfractureprocedure
Microfracture performed by arthroscopic surgery