“The Agili-C trial is very close to real life,” said one of the study’s lead investigators Antwerp University’s Dr. Peter Verdonk. “Randomization is versus current standard of care—either debridement or microfracture. Which is a major advantage of the Agili-C study.”
The randomization allocation ratio is 2:1—for every two patients randomized to the implant, one is randomized to control.
It should be noted that as in previous studies, young patients with small, focal defects but no arthritis, are receiving microfracture. Older patients with large lesions and mild to moderate osteoarthritis are randomized against debridement (small focal defects with KL=0 cannot be treated with debridement).
“We are thrilled to be on the leading-edge of orthopaedic sports medicine and joint preservation,” said Dr. Seth Sherman, a sports medicine orthopedic surgeon who was one of the first U.S. surgeons to enroll patients in the Agili-C study.
“In the U.S., there are limited options for off-the-shelf cartilage repair technologies that can be used by sports medicine surgeons in a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, no burned bridges, strong basic science and clinical track record.”
“Often in studies like this, we enroll a very strict sub-set of young, active patients with a single isolated cartilage defect,” continued Dr. Sherman. “In reality, that’s not the typical patient we see every day in clinic.”
“This study and this implant are different because they are both indicated for a wide range of situations including patients with multiple cartilage defects and even those with mild-moderate osteoarthritis. We can use Agili-C in study patients who are in their 20s or those who are in their 60s. This versatility allows us to consider more patients who may benefit from this procedure.”
The Agili-C study is a prospective, multicenter, open-label, randomized, and controlled, with adaptive sample size. Its primary endpoint is to show superiority of the Agili-C implant over the current Surgical Standard of Care: microfracture and debridement in the treatment of wide range of joint surface lesions.
Enrollees are evaluated at 2 weeks after treatment, then again at 3, 6, 12, 18 and 24 months.
Investigators are using KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation, SF-12 Health Survey, Tegner Activity Score, Anterior-Posterior (A/P) and Lateral knee X-rays and MRI’s to conduct their evaluations.
If the final results will indeed show clear superiority over microfracture and debridement for the treatment of joint surface knee lesions it will truly be a landmark event.
