The Agili-C Study
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.
The investigators plan to enroll a minimum of 250 patients at sites in the United States, Europe and Israel.
Enrollees will be evaluated at 2 weeks after treatment, then again at 3, 6, 12, 18 and 24 months.
Investigators will be 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.
The inclusion criteria are the broadest ever in a knee study. Enrollees can:
- Be between 21-75 years old
- Have up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
- Have a symptomatic total treatable area of as much as 1-7 cm2, in both arthritic and non-arthritic knees.
What Is Agili-C and How Is It Implanted?
The Agili-C is a biocompatible and biodegradable tapered-shaped solid implant. It is manufactured from aragonite (calcium-carbonate), derived from sea coral. When implanted into a pre-prepared osteochondral hole it acts as a 3D scaffold that potentially supports and promotes the regeneration of the articular cartilage and its underlying subchondral bone.
In previously published animal studies, Agili-C demonstrated the ability to regenerate hyaline cartilage—as confirmed by the presence of Type II collagen and proteoglycans, and the absence of Type I collagen—without relying on growth factors, or external stem cells.
One of the key attributes of Agili-C’s 3D scaffold is its interconnected porosity which maximizes cell contact and promotes matrix deposition.
The implant looks like this:
“Basically, what CartiHeal designed with the Agili-C is an implant with ideal porosity that enables simultaneous regeneration of the articular cartilage and remodeling of the subchondral bone,” explained Dr. Verdonk. “These micro holes on top of the biomaterial actually created an environment that is very similar to a controlled microfracture in very small, porous, well-defined and non-variable micropores.”
“I have used this implant for many years and in many patients as part of previous clinical studies. I personally think that its most important capability lies in its potential to restore the subchondral bone, which often is the main source of pain, especially in early osteoarthritis,” added Dr. Kon.
Implanting Agili-C, says Dr. Verdonk, is surprisingly simple. “The procedure to implant Agili-C is very close to what the orthopedic surgeon is used to, i.e., drill the hole, place the implant and push it in. Very user-friendly procedure. Only few minutes per implantation.”
“We also found that it’s very important that the entire implant is surrounded by bone—that it touches bone everywhere. When that happens, it gives incredible etiology and normal reconstruction of the subchondral bone and beautiful hyaline cartilage.”
Dr. Zaslav agrees, “Putting in the Agili-C is very easy. It’s an off-the shelf implant with five years shelf life. It’s an outpatient procedure. One of the nice things is the company developed its own tools to make this a perfect press fit and because it’s a rigid implant, it has to be sunk a little bit below the cartilage, so it doesn’t scratch the other surface. But cartilage will grow in to fill that defect.”
“It’s really an easy, 5-step process to put these plugs exactly in a perfect fit.”
Data Due Dates
Agili-C is a CE marked implant. Prior to this FDA IDE (investigational device exemption) study, it had been implanted in several hundred patients in a series of clinical studies in Europe. These studies were all prospective, multicenter, open-label, and controlled.
The first Interim Analysis of the current study is expected at the beginning of 2020.
If Agili-C proves to be statistically superior over microfracture and debridement techniques for repairing cartilage, especially in the early stages of OA…then, perhaps, it may, finally, achieve the promise of making cartilage repair a routine part of every orthopedist’s practice.
[1]https://clinicaltrials.gov/ct2/show/record/NCT03299959?term=cartilage&cond=knee+arthritis&cntry=US&draw=2&rank=48&view=record
[2] https://www.ncbi.nlm.nih.gov/pubmed/22637204?dopt=Abstract
[3] ibid
[4] Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533.
[5] ibid
