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 was 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 a 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, a synthetic cartilage implant that can be 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
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. 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.
- The Power of Pediatric Flexible Flatfoot Procedures - September 21, 2023
- StimRouter: A Revolutionary Approach to Targeted Pain Relief - August 21, 2023
- Is Cosmetic Foot Surgery Safe? Or Are You Starting Off on the Wrong Foot? - May 17, 2023
44 comments
Leave a Reply
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
I was relieved to read this article because I had cartiva surgery over 2 years ago and have had much more pain since then. My toe aches most days and throbs sometimes during the night. I have never been able to get full motion back in that big toe joint. It has been incredibly frustrating.
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!
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.
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!
Dr.Baravarian I live in Orlando Florida and have been diagnosed with hallux rigidus . I have been to two different foot and ankle clinics both surgeons indicated not to get the fusion I am 57. Both did not use Cartiva at all. They preferred the silastic implant. The one surgeon I saw indicated they can last up to 15 yrs. or better and the one that I am seeing at this time indicated he has had excellent results and never had a failure with the silastic implant? Recently I did get the custom orthotics which has helped some. So I am really confused in what direction to go.?
Greetings,
The only way to get an evaluation short of coming here is to have a virtual consultation. The plus side of a visit is insurance covers it and they do not cover virtual consultations. But since you are on the other side of the country, it really is not practical to fly all this way for that. And would be, in this case, probably more expensive even with insurance covering the appointment cost.
You can request someone to get in touch with you about a virtual consult from here: https://www.footankleinstitute.com/request-a-virtual-consultation
Take care of yourself please!
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.
I had a Cartiva implant in the second toe; which is has failed, just found out by going to another foot surgeon; plus I found out the FDA did not approve an this implant for second toe, they are considering it experimental and investigative. I have been battling the charges with my insurance carrier; since NONE of this was disclosed to me by my doctor. I am not facing having another surgery since I have bone on bone. New doctor has found 2 mfgrs to have FDA approval; however, I was concrete evidence they do; plus the doctor will need to speak to my insurance carrier. This is very difficult for me; since I have pain consistently from my toe; which the pain radiants up my leg. I am so disheartened this was done to me and my original doctor will not see me per his office manager. This surgery was done 11/15/2018.
I am so sorry to read this. You can certainly have a virtual consultation with Dr. Baravarian, who is one of the foremost experts on this and how to fix it. I am assuming you are not near us, so please find a doctor who you are comfortable with and can trust, that is critically important. You should not need to live in pain and there is light at the end of this tunnel, there really is.
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.
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.
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.
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
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.
We are so sorry to read about your situation. You are not alone, which is not something that will make you feel better, I know. But you can have it corrected and either have a fusion or Arthrosuface (https://www.footankleinstitute.com/treatments/arthrosurface-for-hallux-limitus), both work remarkably well.
We have folks travel to us all the time and if you wish to consider that, you know where to find us!
I have to wonder how many of the people it didn’t work for are morbidly obese and weight loss would have helped in the first place.
I’ve managed to lose 15 kg’s and my foot pain has reduced but still have arthritis. So still need to deal with the pain I have left because it’s still affecting my life day to day.
Obesity never helps, that is for sure. But in this situation, the technology has failed many patients. And they will have to again deal with surgery to repair a situation that should have been taken care of the first time. Thankfully the prognosis after a failed Cartiva is not all doom and gloom. But still, it should have never been this way.
I had a Cartiva implant in April, 2017. I never had any pain in my toe joint- the pain I had was from with two bone spurs at the base of my great toe. Actually, the toe joint looked pretty good on x-ray. Once I was in surgery, my surgeon was able to see that my cartilage looked much worse than on x-ray and used the Cartiva. I thought things were moving along normally after surgery.
I had absolutely no pain but one year later, my post-op swelling was still present at the base of my toe. A follow-up x-ray showed that the Cartiva implant had failed and the swelling was because I was “bone on bone”. Luckily, enough bone was remaining so that I can have a traditional implant inserted and I don’t need to get a fusion.
I’m hesitant to undergo more surgery when I don’t have any discomfort but I don’t fit in any of my shoes and have had to buy new ones a half-size larger and wide-width just to fit.
I have a diagnosis of Hallux Limitus on left foot big toe. I have seen two specialists and they have recommended the Cartiva implant. Each MD performed less than 10 implants and they were not all successful. After reading your concerns about the Cartiva implants I am hesitant to get the procedure done. Is their an alternative other than joint fusion to relieve the pain I am experiencing? Or would recommend the Cartiva procedure.
We are not recommending the Cartiva at all right now. There is the Arthrosurface which has been very successful. You can read about here:https://www.footankleinstitute.com/treatments/arthrosurface-for-hallux-limitus.
I hope this helps!
Have you ever heard of a patient rejecting the implant material???
Greetings Martha,
No, I have not heard of that.
Bob
Dr. Bob Baravarian
Assistant Clinical Professor:
UCLA School of Medicine
Director and Fellowship Director:
University Foot and Ankle Institute
What are the symptoms of a failed implant? I am 2 weeks post-op and seem to be doing well. My doctor said each implant surgery he has performed has been successful. Just curious what symptoms suggest failure or potential failure.
Virtually all problems begin with pain. If you have increasing pain, see your doctor. Though there have been a high failure rate of Cartiva implants, not all fail, so please do not expect the worst. Just do not ignore pain and stay in touch with your doctor during your recovery. Be well!
I had a Cartiva implant on June 13, 2019. The first 8 weeks were pretty good but the nerve pain seemed to never go away and then by 3 months post op I had increased swelling, pain and my whole foot became a little dusky looking. I had a repeat c-ray that shows the implant failed. I am back in a walking boot awaiting a surgery date. I will be discussing the procedure next week, I’m thinking I would prefer another type of implant versus a fusion. I want to know if Wright Medical is helping to cover revision surgery costs? I know there is litigation regarding their hip implants and wonder if the failure in the artificial cartilage in the hip implant is made of the same material as the Cartiva???
We do not know the particulars of the hip implant since we have never used them for obvious reasons. Take a look at the Arthrosurface implant, which we have had excellent results with.
Thanks very much for your informative information and Q&A. My wife had a consult for a Morton’s Neuroma and because she had occasional pain in her big toe and evidence of arthritis the surgeon recommended a Cartiva implant procedure to address that at the same time. Now 3.5 months later she has more and constant pain in her toe, greater than it ever was before. And while extremely active before her mobility is now limited and we are questioning the whole procedure although that is water under the bridge now. We were led to believe that the failure rate was 7% and it was on that basis that we proceeded as we did. Now I am reading more and more articles that suggest the failure rate is much higher. While we are hopeful it may improve in the coming months, we are also being realistic and anticipate that fusion will be the next step. The question we have regarding fusion is will it allow her to get back to an active lifestyle which included running, cycling and hiking?
Hi Ian,
Yes she will be able to do everything without pain other than wearing high heels. But heels up to 2 inches should be okay.
I had my Implant on the 1st of July 2019. My post surgery recovery was going great with the exception of my staples were left in a week to long and my skin started growing over the staples. After weeks of follow up because what was thought to be edema, it was later diagnosed as Lymphedema. I was treated twice a week by a physical therapist who specialize in lymphedema therapy for 6 weeks (no real change). My surgeon also said that the implant moved and recommended a second surgery. What he is suggesting is locking the implant in place by drilling a screw at a angel thought the bone. Does this make sense? I have been in pain since Aug. Now that the weather is cold, I had to buy shoes 2 sizes larger then prior to the surgery and of course the other foot is smaller. I will be having another follow up and will be talking about the next surgery next week. Please advice if this idea of locking the implant in place is feasible or I should suggest to him the Arthrosurface. Thank you. (I do miss wearing my heels).
Unfortunately we cannot give medical advice to those who we have never examined or reviewed their medical records, history and films. I am so sorry.
We do have a a virtual consultation where we can do that, but there is a charge and unfortunately it is not covered by insurance. If that is not something you want or can do, please get a second opinion so you are comfortable with your next steps.
If you want to learn more about our virtual consult service, you can request it here: https://www.footankleinstitute.com/request-a-virtual-consultation
I hope this helps somewhat.
I had the Cartiva implant inserted over 1.5 years ago and my toe feels great. This was after a failed chelectomy. I am very active and have a good BMI , should I expect issues or is mine considered a success? I wish I could take a look at published reliability numbers and success rates.
There is no definitive answer to your question, but we know that not all Cartiva implants fail. A lot do, too many do, but you are fortunate. So just enjoy your return to normalcy and worry about it if it begins to be a problem. We have plenty of other things to worry about these days. I am very happy for you.
Hi I live in the UK and have just been to see my consultant with regards to arthritis in my big toe joint. He has recommended Cartiva and directed me to their site Cartiva.net. At first glance I was very optimistic about this procedure but started looking into it further and came across your site. I now wonder if I should go for the Arthrosurface option instead but don’t know whether this can be done in the UK and under the NHS? Would you know if this procedure is being done over here please?
You need to contact the company to see if and who is offering it on the other side of the pond. But it has been our go to procedure since Cartiva has turned out to have a terribly high failure rate.
I just received a Cartiva cartilage implant because I am allergic to nickel and I was told that all the other implant choices contain nickel. Does this mean that fusion is the only choice I will have if this Cartiva implant fails?