The CartiHeal™ Agili-C™ implant is an FDA-approved option for repairing damaged cartilage in the knee, including in knees that already have mild to moderate arthritis. It is a small, porous scaffold made from aragonite, a natural form of calcium carbonate, that is placed into the damaged area so the body can regrow cartilage and the bone beneath it. Dr. Andrew Dold, a board-certified, fellowship-trained sports medicine surgeon in Frisco, Texas, offers CartiHeal Agili-C alongside the full range of cartilage repair and transplant procedures.
- FDA approved in 2022 for cartilage and osteochondral (cartilage and bone) defects in the knee
- For damaged areas of about 1 to 7 square centimeters
- Approved for knees with no, mild or moderate arthritis (Kellgren-Lawrence grade 0 to 3)
- Single surgery; no donor tissue and no cells grown in a lab
- Gradually absorbed by the body and replaced by your own tissue
What is CartiHeal Agili-C?
Agili-C, made by Smith+Nephew, is a cell-free, off-the-shelf implant. It has two layers: one that sits in the bone and one that sits at the level of the cartilage. Its porous structure, made from purified aragonite derived from coral, acts as a framework that the body’s own cells grow into, rebuilding both the cartilage surface and the bone underneath. Over time the implant is absorbed; according to the manufacturer, it is largely resorbed within about 18 months.
Because it treats both cartilage and the bone beneath it, it can be used for cartilage defects from injury, wear or osteochondral lesions.
Who is a candidate?
- Knee pain from a cartilage or osteochondral defect seen on MRI (ICRS grade 3 or higher)
- A damaged area of about 1 to 7 square centimeters
- No arthritis, or mild to moderate arthritis (not severe, bone-on-bone arthritis)
- Symptoms that have not improved with non-surgical treatment
Agili-C is not appropriate for knees with severe arthritis, very deep bone defects (more than about 8 mm), defects without healthy surrounding bone, or active infection. Problems such as poor leg alignment, an unstable kneecap, a torn ACL or a damaged meniscus may need to be treated as well, sometimes at the same time. For severe arthritis, osteotomy or knee replacement may be better options.
What does the research show?
Agili-C was approved by the FDA in March 2022 based on a randomized clinical trial of 251 patients that compared it with the standard treatments of microfracture or debridement (cleaning up damaged cartilage). At two years, patients treated with Agili-C had about twice the improvement in knee pain and function scores (KOOS) compared with the standard-treatment group. As with any procedure, individual results vary, and Dr. Dold will discuss what is realistic for your knee.
What happens during the procedure?
The procedure is typically outpatient. The knee is first examined with an arthroscope (a small camera) to confirm the size and location of the damage. The implant is then placed through a small open incision: the damaged area is prepared, a precisely sized hole is made, and the implant is press-fit into place just below the level of the surrounding cartilage. Larger areas may need more than one implant.
Recovery
Recovery is gradual because new cartilage and bone take time to form. As a general guide, physical therapy starts within the first couple of weeks, crutches are used for a period to protect the knee, and most patients regain normal walking and motion over about 3 months. Many notice meaningful improvement by about 6 months, and return to higher-impact activities and sports often takes 9 to 12 months. Dr. Dold will give you a specific rehabilitation plan based on the size and location of your repair and any other procedures performed.
Why see Dr. Dold
- Board certified by the American Board of Orthopaedic Surgery, with subspecialty certification in Sports Medicine
- Sports medicine and arthroscopy fellowship at NYU Langone / Hospital for Joint Diseases; orthopedic residency at the University of Toronto
- Fellow of the American College of Surgeons (FACS), the American Academy of Orthopaedic Surgeons (FAAOS), the American Orthopaedic Association (FAOA) and the Royal College of Surgeons of Canada (FRCSC)
- Published research on knee ligament and meniscus surgery, including The Posteromedial Corner of the Knee (JAAOS, 2017) and transtibial meniscal root repair (KSSTA, 2017)
- Team physician and surgical consultant to Rugby Canada; has cared for professional and Olympic athletes from the NFL, NBA, NHL, MLS, PGA Tour, Major League Rugby and USA Gymnastics
- D Magazine Best Doctors (Collin County), 2019–2026 · Rated 4.9 on Google
Frequently asked questions
What is CartiHeal Agili-C?
An FDA-approved implant made from aragonite, a natural form of calcium carbonate, that is placed into a damaged area of knee cartilage in a single surgery. It acts as a scaffold for the body to regrow cartilage and the bone beneath it, and is gradually absorbed.
Is CartiHeal FDA approved?
Yes. The Agili-C implant received FDA premarket approval in March 2022 for cartilage and osteochondral defects in the knee.
Can CartiHeal be used if I have arthritis?
It is approved for knees with no, mild or moderate arthritis (Kellgren-Lawrence grade 0 to 3). It is not used for severe, bone-on-bone arthritis.
How is CartiHeal different from microfracture?
Microfracture makes small holes in the bone so marrow can form repair tissue. Agili-C places a scaffold that supports regrowth of both cartilage and the bone beneath it, and in the trial used for FDA approval it showed greater improvement than microfracture or debridement at two years.
How is CartiHeal different from MACI?
MACI requires two surgeries: one to collect cartilage cells, which are grown in a lab, and a second to implant them. Agili-C is an off-the-shelf implant placed in a single surgery, with no donor tissue or lab-grown cells.
How long is recovery after CartiHeal?
Physical therapy starts early, most patients regain normal walking and motion over about 3 months, and return to higher-impact activities and sports often takes 9 to 12 months. Your plan depends on your repair.
Is CartiHeal covered by insurance?
Coverage varies by insurance plan, so it is worth checking with your insurer before surgery.
Medically reviewed by Andrew P. Dold, MD, FAOA, FAAOS, FACS, FRCSC. This page is general information, not medical advice. Individual results vary.
