RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect®
in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of
microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible
patients attended two screening visits and were booked for arthroscopy approximately 2 weeks
later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a
procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar
tissue. Patients randomized to MF had the procedure performed at the time of their
arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the
arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee
procedure, during which the ACI procedure using ChondroCelect® was performed. Patients
subsequently followed the same rehabilitation program and had follow-up assessments up to 12
months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000
protocol. Subject to satisfying the eligibility criteria, patients who had participated in
the initial 12 month trial could enter the extension trial. The 12-month visit for the
initial study was the baseline visit for the extension study. During the extension study,
patients have follow-up assessments up to 60 months post-surgery.