When the Cartiva Big Toe Joint Implant Fails

Big Toe Arthritis Treatment, University Foot and Ankle Institute

The Cartiva implant was considered to be a revolution in great toe arthritis therapy. It came out with a splash and the original studies to get the implant through FDA approval showed incredible results.

Our group, University Foot and Ankle Institute, and me in particular, were involved with helping launch the product and educating surgeons on how to use the implant. Initially, we were very excited to be involved but quickly realized there was something wrong.

What is Cartiva?

The Cartiva implant is a mainly water based implant. It is placed in the great toe joint with a hole that is made into the metatarsal head. The implant is pressed fit into the hole and acts similar to regular cartilage, allowing motion of the joint.

The procedure is extremely easy to perform and reproducible in the operating room. It is also easy to teach and patients have a fairly rapid recovery after the surgery.

The original studies performed to get FDA clearance were extensive, with over 10 surgeons involved in the study. The results were amazing in the study. Almost all of the patients had pain relief and would do the procedure over again. The study blew my colleagues and me away.

Why does the Cartiva implant fail?

The only problem with the Cartiva implant is that the results we saw at our institutes were far less successful than those noted in Cartiva’s studies. We were seeing failures due to the implant slipping into the bone, a process referred to as subsidence.

The implant would be left 2-3mm out from the surface of the bone during surgery and it was definitely outside of the bone following surgery. However sometimes, even on the first visit after surgery, the implant had sunken into the bone. We were far from the only ones noticing this occurring.

We ordered MRI and CT scans to figure out why the implant was failing. We also reached out to other early adopters and learned they were having similar issue. Our results were very different from the original study.

We felt compelled to find out what was going wrong and we reached out to the company and alerted them to the issues. I recently met with the company that owns Cartiva and its representatives at a national foot and ankle meeting. I alerted them to the issues and mass failures we are seeing and suggested they see why this is happening. They were very courteous but less than interested and began to quote studies saying the implant and their internal studies are great.

Why University Foot and Ankle Institute no longer uses the Cartiva Implant

Cartiva Implant for Great Toe Arthritis, University Foot and Ankle Institute

Cartiva, a synthetic cartilage implant that can used to treat great toe arthritis.

This made me think that as a foot and ankle surgeon, I am morally obligated to report this issue to the manufacturer, to our patients, blog readers and the general public. This issue must be investigated by the manufacturer and they must help those with failures find hope and get out of pain.

As a result of this, we have decided that the Cartiva implant’s real-world results are not up to our standards and we have stopped using them. Over time, we have begun removing the implant and replacing it with other options. Now that we have seen A LOT of other surgeons’ patients coming to our clinics with the same issues, we feel this is an epidemic problem.

The goal of this article is to help those who have a failed Cartiva implant and to tell those who want to get one to NOT GET A CARTIVA IMPLANT until further notice. We can now see that about 50% of the implants we have done have failed. This is far below our normal 90% to 95% surgical success rate for the most complicated cases and the most advanced technologies. That is what we and our patients expect. Anything lower is not acceptable.

What to do if you have a failed Cartiva implant?

The good news here is it’s fixable. There are multiple companies working on replacement systems if you must have a toe joint replacement. I will detail these further. If you just want to be out of pain, get on with your life and have no more issues, your best option is a great toe joint fusion. Fusions work great when done right. A woman can wear a 2-inch pump following a fusion, and for men it is the best surgical option.

Arthosurface implant for failed Cartiva Implants

Arthrosurface for great toe arthritis treatment, University Foot and Ankle Institute

UFAI’s preferred procedure is Arthrosurface.

If you are a patient who really wants the toe to move, Arthrosurface has devised a special implant to fill the Cartiva hole and fit a replacement on it. The original Arthrosurface implant had an 8mm stem on it and was not able to be placed in the 10mm Cartiva hole.

At the last national meeting, we discussed this with the Arthrosurface team, and I am happy to report that we now have a 10mm stem that fits into the Cartiva hole. This implant is a wonderful joint replacement system that is very strong and sturdy, works well and allows for immediate weight bearing. We like the Arthrosurface implant, as the best option for a failed Cartiva in the case a patient does not want a joint fusion.

My personal thoughts about joint fusion

I would not be doing my job for my patients if I didn’t speak about joint fusions as an option. Any implant will fail with time and wear and tear. A fusion will not. Any implant can get damaged with pounding and hard exercise. A joint fusion will not. Any implant will need to be replaced again, if only because of time. A joint fusion will not.

If you are a man and you do not need to go on your toes for any major reason, fuse your toe. If you are a woman and don’t need to wear more than a 2-inch heel, fuse your toe. This will allow you to be out of pain and get on with your life with no setbacks and no need for further surgery.

I hope this article is helpful and gives patients suffering Cartiva failure hope. Ultimately, my suggestion is do not do a Cartiva implant. It is not worth the risk. For those who experienced a failed Cartiva implant, I suggest you strongly consider fusing the great toe as it will be a one and done surgery with an exceptional outcome potential.

If motion of a toe is a must, try the Arthrosurface implant and make sure your surgeon is aware of the 10mm new stem option, which is a must for proper replacement of the Cartiva implant.

If you would like more information about treatment options for big toe arthritis, please call us at (877) 736-6001 or visit us at www.footankleinstitute.com.

Dr. Bob Baravarian, DPM, FACFAS
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Dr. Bob Baravarian, DPM, FACFAS

Dr. Bob Baravarian is a Board Certified Podiatric Foot and Ankle Specialist. He is currently a member of UCLA Medical Group, Chief of Podiatric Surgery at Santa Monica/UCLA medical center and Orthopedic Hospital and an assistant clinical professor at the UCLA School of Medicine. He also serves as co-director of University Foot and Ankle Institute. He is Editor Emeritus of the international medical journal, Foot and Ankle Specialist.

Dr. Baravarian has been involved in athletics his entire life and played competitive tennis in high school and college. He has an interest in sports medicine, arthritis therapy and trauma/reconstructive surgery of the foot and ankle. He servers as a consultant to the ATP (Association of Tennis Professionals) tour, multiple running organizations and several shoe manufacturers. He is also fluent in five languages (English, French, Spanish, Farsi and Hebrew),

Podiatrist Dr. Bob Baravarian is available for consultation at the Santa Monica, Sherman Oaks and UCLA Westwood offices.
Dr. Bob Baravarian, DPM, FACFAS
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19 comments

  1. Good Day, Thanks for this article it was posted on FB Cartiva Support Group. Which is also full of failed implants stories. It was nice to see something written by a Doctor to confirm what so many of us experienced. After my failed Cartiva and subsequent fusion I had the time to research more about the FDA s approval. Thought it was very interesting the questions that were used for the boards approval. Which was aware the implant was not better, equal or even close to the fusion it was compared to. At least thats the wording as I understood it. Just thought I mention it for if I saw those questions I would not have had the implant. THANKS AGAIN. https://search.usa.gov/search?utf8=%E2%9C%93&affiliate=fda&sort_by=&query=Cartiva

  2. You need to flex your big toe to walk properly.

    To be fused will limit range and cause chaos in your body in other places over time. A restriction in the body does cause issues in other areas of your body like your hips and lower back. To say a fusion will allow you to be out of pain and get on with your life with no setbacks and no need for further surgery is just not right.

    A fusion will restrict range of motion and cause problems elsewhere and you know this!

    • Janet,

      What you are stating is not exactly true. If positioned properly, a fusion acts like a normal push off position of the toe.

      Bob Baravarian
      Assistant Clinical Professor:
      UCLA School of Medicine
      Director and Fellowship Director:
      University Foot and Ankle Institute
      Los Angeles, California

      • I live in Baltimore MD. My cartiva implant also didn’t work. Can you recommend someone in my area to do the arthro surface or a fusion? I am miserable and I need to get this repaired. Thank you!

        • We are so sorry to read about your Cartiva failure. We do not know folks in Baltimore but you can call the folks who make the rthrosurface device and ask them for qualified surgeons in your area. I hope that helps! I hope this helps!

  3. Can you recommend a surgeon in Michigan to perform the arthro surface post cartiva failure? My surgeon said they don’t work. I’m not ready for a fusion.

  4. I had the implant surgery may 6th. I am very satisfied and I can’t believe how much I am able to do now. My surgery and doctor were incredible . The recovery was only 3 weeks and I could walk on it right away with special shoe.

    • That is great news. Cartiva should certainly work for all people, but sadly the evidence shows an unacceptable failure rate. But we are thrilled that is has been good for you, that is exactly the way it should have been for everyone. Thanks for sharing this!

  5. Constance Ferrell

    How long should I wait until I consider my Cartiva implant a success or failure? I had the implant Feb. 21/19, so it’s been nearly 5 months. It feels like there is a permanent bruise or something on the underside of my metatarsal, and I still walk on the side of my foot to lessen the pain. With 2 knee replacements in the last 1 1/2 yrs., I need my foot to work properly!

    • Generally think is that by now, it would probably be considered a failure. You should get it checked out as there are alternatives to living in pain. If you want to come see us, we can certainly take care of the situation as we have been sadly correcting a lot of Cartiva failures. If we are too far. please see someone, you deserve to feel better.

  6. What do you know about severe metatarsal pain that began about 20 months after what seemed to be a successful Cartiva implant in my severely arthritic bit toe? My orthopaedic surgeon recommended that my orthotic be refitted with a pad in the metatarsal region – but that is causing even worse, searing pain.

    • We would have to see you in order to comment on what could be done for you. But do not give up as you are your best advocate and you should not live in this kind of pain.

  7. If fusion is so great then why such the fuss about needing proper range of motion at the first mpj? That lack of motion must effect all proximal range of motion don’t people with hallux limitus get more knee and back pain?

    • It is not that a fusion is so great, but one alternative in particular has had some terrible repercussions for patients. Compared to that, a fusion ends the pain and keeps you quite mobile, while the failed implant leads to debilitating pain and immobility. When framed that way, I think you will better understand where we are coming from.

  8. Had Cartiva implant Nov 2018. Surgeon told me it receded around May 2019. In so much pain that I am now planning to go to pain center to try to get some relief. Thank you for the article. Now just need to find a doctor I feel I can trust to do the next surgery. Not blaming the first surgeon, as I understand it is the mechanics of the Cartiva surgical process. However, being in constant pain without relief for so long is definitely causing me anguish.

  9. Good morning Dr. Baravarian,
    I am scheduled for surgery of my arthritic right big toe.
    I initially decided on the Cartiva implant, but after reading your article have reconsidered.

    My question is this; on your suggested “revision procedures” your recommend a bone substitute material at the base OR a bone cement placement . Are either of these revisions considered during the primary implant procedure to prevent the problem in the first place? And if so, when might you be performing this technique? Thanks for your assistance.

    • Cartiva right now is a no go for us. We have spoken with many surgeons and the company and I don’t have a good solution to offer patients right now using Cartiva.

      Bob Baravarian
      Assistant Clinical Professor:
      UCLA School of Medicine
      Director and Fellowship Director:
      University Foot and Ankle Institute
      Los Angeles, California

  10. I had the cartiva surgery and it failed also. The pain is less than before the surgery but I still have pain. My surgery was done in Colorado Springs, CO. And on my exit interview I did not really understand exactly what my doctor said except that I should wait at least a year. I sent the report to my daughter and she said that means the implant failed. I sent it to my cousin in Germany and she thought the same as my daughter and sent me this article. Well now it is confirmed the implant failed and I still walk around like a cripple because of the pain. Wish I would have seen this article before my surgery and I would have decided for the fusion surgery.

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