Source: Hiroshi Inui, Shuji Taketomi, Kensuke Nakamura, Seira Takei, Hideki Takeda, Sakae Tanaka and Takumi Nakagawa

A new study has pitted customized knee implants against off-the-shelf implants. The resulting paper, “In Vivo Tibial Fit and Rotational Analysis of a Customized, Patient-Specific TKA versus Off-the-Shelf TKA,” appears in the May 25, 2018 edition of the Journal of Knee Surgery.

Gregory Martin, M.D., with the department of orthopedic surgery at Preferred Orthopaedics of the Palm Beaches, Palm Beaches, Florida, and co-author on the study, told OTW, “We were interested in undertaking this study because many people have persistent pain after total knee arthroplasty using off the shelf implants that could be explained by poor implant fit and/or malrotation. We hypothesized that a customized knee implant would outperform off-the-shelf implants concerning fit and achieving correct rotation.”

“The most important result was that with off-the-shelf implants there is a serious compromise between tibial sizing and tibial rotation, both known sources of pain after total knee arthroplasty. This compromise is basically eliminated with the use of customized implants.”

“With approximately 20% of total knee patients not satisfied after the procedure, customized implants need to be taken seriously as a means to reducing persistent pain and improving patient satisfaction.”

“These results just make sense. We wouldn’t wear a shirt or a pair of shoes that doesn’t fit right, so why would we accept any less for our patients when we are implanting a medical device in them!”

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43 Comments

  2. I have been researching the same thing. What city are you located in? Would love to know your results!
    Thanks

  3. I was looking into Conformis Knee surgery for myself, but then I found all the lawsuits against it. Can someone tell me how it is today? Is it reliable or still having issues?

    Thank you

    1. I am very interested in hearing about lawsuits. Have been very intrigued by Conformis. It makes sense to me.

      1. I’m having a TNR Sept 2020 using conformis in Florida . Anyone have one recently ? It’s out patient and I’m home that day … any comments ??

        1. Hi. I had a Conformis TKR December 2018. My recent and progress through PT went more quickly than what I heard from other folks who had other types of devices and surgeries. My surgeon did a quadriceps sparing type of surgery which is very important. I am so happy with the knee as I have no pain and excellent range of motion and strength. I have no regrets choosing Conformis, and an excellent surgical team.

          1. I am having a TKR in a few weeks and read about conformist.Extremely interested!Im a very active 50 year old female with a ten year old son.My husband and I are just starting to raise our son and I would like the best possible outcome for my family who has a lot of living to do .I Also.,need both knees done!I appreciate any insight at all !Thank you so very much!God BLess!!

          2. Hi Janis, Who was your Surgeon and where did you have your surgery? I am scheduled for my Conformis knee replacement this Oct. 12, 2021 at Florida Orthopedic Institute in Tampa, FL.
            How was your healing time and were you able to resume all your normal activities?

            Sincerely,
            Lynda

        2. I have had two conformist replacements…one three years ago, one five. Fantastic results and not one problem. To me, it made perfect sense to be fitted with a custom knee.

    2. Every major manufacturer has lawsuits. DePuySynthes, ZimmerBiomet, Stryker, Smith&Nephew. As long as there are lawyers and even one patient is dissatisfied there will be law suits

  6. Is conformis knee better than Off the shelf knee like styker triathalon?
    I need to choose one and different doctors are giving me different opinions and I don’t know how to decide

    1. I had a TKR on my left knee in 2014 using the Conformis system. I did research before choosing them but, very glad I did. I don’t know about any lawsuits but, I HIGHLY recommend Conformis. I have had absolutely no issues since the surgery and was only out of work for 2 weeks….!!!!! I do know people that have used Stryker knee systems and have had numerous problems. If you choose Conformis, I don’t think you’ll be disappointed.

  7. Same here! Different advice from different doctors. I am having a difficult time deciding.

  8. I found this information about ConforMIS Recall History. The first one is the most disturbing
    * The ConforMIS iTotal G2 was approved in January 2011 via the FDA’s 510(k) loophole, which requires little safety data and only some information concerning the products’ efficacy.*
    * In July 2009, recall 10 of the iUni sets due to concern about microscopic cracks that could potentially increase a patient’s risk of premature revision surgery. The Class II recall did not cite any patient injuries.
    * ConforMIS recalled 1,427 units of the iTotal CR knee replacement and added prominent updates to the surgical technique guide. The Class II recall was issued in August 2012.
    * Between January 2011 and March 2014, the FDA received about 30 reports of spacer dislodgment or tibial tray loosening associated with the ConforMIS iTotal G2 Knee Replacement System. This caused its users a number of complications including immobility, bone damage, and the need for revision surgery.

    1. I have also been given conflicting advice by two surgeons about a conformis partial knee replacement, my reaction is that, logically, a purpose made replacement should be the better option. However, this is a difficult decision for me and I would appreciate any feedback from anyone who has had the conformis replacement

      Thanks

      Jim Leighton

      1. Jim, My Conformist patellefemoral replacement was trouble with kneecap maltracking EVERYTIME knee bent 30-35 degrees just few weeks from surgery placing it in. All Patella dislocation /subluxation are very unpleasant. My knee was fine, not one bit of trouble not O.A either before trauma. I fell and landed only on that knee, with all my weight (no jokes, truly weight 125 lbs) and force creating few minor fractures but knee would never glide back again smoothly after fall. This Friday, October 30 my custom made Conformis replacement is being removed and a total knee replacement will be installed. Two year anniversary of fall to the day and back to Operating Room for surgery # 3 on this knee. First surgery, Conformis’ partial replacement installed As soon as surgery swelling reduced and able to flex post-op knee only 30-35 degrees, kneecap would maltrack in it new replacement track and dislocate laterally (towards outside of knee) Patella dislocations are not pleasant. Every step, kneecap pops out of place. Ortho MD blamed it on my VMO muscle lossing strength from surgery After intensive Physical Therapy, which didn’t improve patella’s dislocating one bit, after cancelling family vacations and our yearly Vegas trip plus NOT being able to play cars and trains with my grandsons on the floor, not wanting to go out due to after normal work shift, I would be having tears flowing down cheeks while I drove home from job. Another evening of elevating knee, icing and being in agony with knowing here comes another night of waking up with sharp stabbing pain in post-op knee. After 13 months of this circle of loading sanity and life sucking out of me, Surgery #2 was for Confirmis partial knee replacement REVISION surgery. More time off work, in fact, my work transferred me to a different location because all the time off for surgery and rehabbing all over again and missing work. Sad part, all that hell of surgery #2, revision never helped. As soon as surgery #2 swelling reduced, my patella was totally maltracking and dislocating towards outside of knee STILL. I returned to work, at new assigned different location but now in worse agony. Surprised, I switched Ortho M D. I researched until I located different doctor in different ortho group who received only 5 stars on all M D rating sites. It was reported that new doctor listens to his patients ..really, too good for ortho right?!? He does listen and discusses my knee not at me but with me. First exam with new ortho surgeon, he flexed my knee backwards alittle and witnessed my patella jumping out of track. Instantly, Doctor stated that he can’t fix. It’s a design error and he stopped putting partial replacements in his patients because of this reason. How and why I wanted to know since this is a custom copied end of my femur middle groove. Dr replied, “some designs just don’t work like it looks like it would on paper.” Only way to stop this patella torture, is to get a total knee replacement and that will stop my knee cap from repetitive subluxating. Surgery isn’t going to be the easiest with my femur bone and back of kneecap already sawed into. Third round at Physical Therapy and out from my transferred job location again. Jim, bet you are thinking now why did I ask for feedback about Conformis partial knee replacement?. Maybe the other two locations for Conformis’ partial knee replacements might be just the greatest?!? I seriously do not recommend the patellefomoral Conformis partial replacement. It’s made me miserable, unable to normally function as before my fall and THREE trips to operating room, three rehabbing times, missed so much work time and husband used good bit of his vacation time running me to MD, hospital and P.T. until I was cleared to drive. Jim, I seriously wish you the very best and hope my report is not too late for you!! Hopefully, this Friday’s total knee replacement, which is NOT Confirmis brand being installed,,, all ends well and few months I’ll update this posting with a positive ending. Kathy S outside Atlanta GA

        3. Oh my goodness. So sorry that you went through all of this. I need a knee replacement and just came across Conformis. How did your total knee replacement go?
          I did find a great doctor who I will see soon. I dont believe he does Conformis or any type of customized implant.
          thank you for any info you can provide. hope the new knee is doing great.
          Sonia Turner

      2. I too have heard conflicting reports from surgeons. As a Conformis implant must require some specialist training, I would expect that many surgeons would be just as happy to continue with the procedures they have used for years. In this case, these surgeons would have to boo the Conformis implant.

        After much research, I chose Conformis and had my TKA on 5/3/21. I am blown away with the results so far and looking forward to playing golf again 12 weeks post op.

        Rusty

        1. love it. thank you for saying this. i am getting a full knee replacement Conformis in september. makes sense that the recovery is quicker than a stryker knee replacement.

    2. Those real examples are all 10+ years old and the results of the law suits isn’t even mentioned. Anyone who pays a filing fee can bring a law suit. I’ve had 2 total knee replacements with the Conformis itotal knee. The first was March 2019, it’s fully recovered, and I’m very happy with it. The second was 29 days ago and I’m way ahead of my recovery pace the first time.

    1. HI Kathy, all of my damage is under my kneecap; however, I have been told that I’m not a good candidtae for partial (knee cap only) replacement because my arthritis os so bad I am so athletically active. My doc said that I would be a good candidate for conformis; however, I am concerned that I may end up with a knee replacement like yours. Did you think of your replacement as a knee cap only/partial or is that just what you ended up with? I also live outside of Atlanta (Johns Creek) and would love to here from you for advice/recommendations if that is possible.

      Thank you!
      Cathy

  10. Janis thanks for your comments. Where did u have your surgery done. I am trying to schedule soon. Still trying to just adjust use in order to avoid but starting to miss way too much.

  11. I had bilateral (both knees) TKR surgery in December 2019. My Conformis implants were not my Doctors first choice, but he has used them in the past successfully. After surgery, which went very well, he expressed that it was probably best that I had Conformis implants because my knees are very different from each other.
    I am coming up on my one year anniversary and I am mixed on whether I consider my results successful. I am able to walk & hike downhill, something that was too painful before the surgery. Yet each step still has some pain and stiffness that I try to ignore. Even rising from a toilet is not easy. So I’m not pain free. There is pain & stiffness doing the frog kick in a pool, sitting on the floor with legs cross bent, or trying to do lunges in exercise class. Lastly, my flexibility is just 140 degrees, which means I need 2 or more blocks to do child pose and cannot reach back to hold my knee for a quadricep stretch. I was hoping by now to be out of pain, stiffness, and with more flexibility than I currently have. Others I know with shelf implants have better results and one other person I know had worse. Maybe with time I can update this report with better news, but for now not sure where I stand on providing a recommendation.

    1. Hello everybody,
      I am from Bulgaria, Europe, EC, and I had a TKR custom made knee replacement, the Swiss system ORIGIN Symbios on 15th October 2020. This was the most expensive option, but i decided to do it, because it was recommended to me, compared with the On-the-Shelf option. Almost 2 months since, I walk to short distances, about 400 meters, I climb stairs upwards with both legs. However, I still feel some stiffness and pain, my knee is still swollen and hard when I touch it, my knee and my leg (left) look different from the other one (right, healthy). Downstairs is not possible either. Is that normal? When should stiffness, pain etc. totally disappear, if ever? Some say 6 months, 8 months, 12 months, but some are not happy at all? What is the real truth?

      God bless you all!

    2. I improved considerably after the one year point. I’m at 28 months post op from my first Conformis itotal knee replacement and I remember having more pain and stiffness at 1 year than I do now. 140 degrees of flexion is OUTSTANDING! It’s rare that anyone gets near that. The vast majority of us are just hoping we can achieve 120-124 degrees, and that’s the goal in PT. I’d be so happy is I got to 140 degrees, but there’s no chance.

  12. Can anyone recommend good website(s) to read about the custom TKR options and to identify surgeons who do them? Thanks!

  13. I am researching what to do for my partial knee replacement that must be done – right knee, meniscus area.

    I am struggling to determine whether robotic makes sense (Stryker) vs custom implants (Conformis). And then I read that Stryker paid Conformis to license their technology, and just this last April received FDA approval.

    https://www.orthoworld.com/conformis-hits-regulatory-milestone-in-agreement-with-stryker/

    The 3rd major consideration is which doctor. And do I want to travel to find the best one. I really like http://www.healthgrades.com for the doctor reviews people leave. I live in Virginia, but here’s in example of one of the best rated doctors I’ve found that does Conformis, and he’s in Tampa Fl. https://www.healthgrades.com/physician/dr-brian-palumbo-x2qpb?leave-review

    This is the best rated doctor I’ve found locally, but he said he’d probably use a Zimmer – he doesn’t do Conformis. But his reviews are outstanding:

    https://www.healthgrades.com/physician/dr-joseph-gondusky-xmnhh?referrerSource=autosuggest

    Tough to decide!

    1. Steve, R. Brick Campbell, MD in Virginia Beach, VA is an excellent MD using the CONFORMIS. He has replaced my shoulder and performed two knee surgeries on me(not TKR). He is experienced, personable, still on the young side and well respected in the medically community and community as a whole. I highly recommend him!

  14. I’m a 60 year old male and have had both knees replaced, one almost 10 years ago and the other about 8 weeks ago. Both are Conformis replacements. I’m very happy with Conformis. Didn’t have any issues with my first one and doing really well so far with the 2nd. My main sports are skiing and golfing and after the first TKR I was able to do both without issue, aside from the arthritis in my non-replacement knee. Eight weeks out from my most recent surgery, things are going well. My flexion and extension are very good according to my physical therapist and I’ll probably stop PT after 2 more sessions. I changed primary care physicians last year and during my yearly physical in 2021 he commented on how good my extension and flexion are on the leg with the 10 year old prosthetic.
    I live in Boston MA and had both surgeries done by Wolfgang Fitz out of Brigham and Woman’s Hospital. Highly recommend him. He is one of the original “founders” of Conformis so has long history with that product. He was recommended to me by a nurse friend. One thing that makes me feel good is that every medical professional I’ve dealt with – nurses, anesthesiologists, X-ray techs, administrators, literally everyone – says Fitz is the best. My experience with him has been excellent. He’s very demanding of the people he works with which makes me feel good. He’s on top of the other caregivers working with me.
    Good luck with your decision. Be diligent in your preparation and rehad and I’m sure you’ll be successful.

    1. Hi Mark,
      I’ve been on the fence about the Conformis knee replacement but your review has me booking an appointment with this very doctor this coming Tuesday. I’ve dealt with the Head of Orthopedic Surgery at Brigham and Women’s about TKR ( he actually had this colleague do Conformiss on him) and when I asked him the difference he grabbed Wolfgang Fritz card and handed it to in a huff. I replied to him I’m just asking the difference between the two because I don’t know and if “you” had it it must be good? . Told me to decide and let him know🤦‍♀️. I know surgeons are difficult but geeze. Thanks for your review, I want to be on my Peloton again.

      1. Please read this whole review to gain the full picture of my Conformis knee journey as it starts ok but deteriorated over three years
        I had a Conformis knee in September of 2018. From the first time I stepped on it while in the hospital I knew it was longer than the other unaffected leg but I was told that “everybody says that” and that it would stretch and adapt . I rehabbed vigorously and effectively, gaining a really good range of motion as I am a motivated person A good and acceptable result except it never really completely stopped hurting but I could live with it
        I was mostly satisfied for 12 months but the pain began to escalate So I began PT again trying to work it out. Also I began to have back pain which I never had before At 15 months the knee and back pain escalated and both have plagued me for the last two years. Desperately seeking an answer I consulted with multiple Orthopedic surgeons as well as pain management specialists I just had a laminectomy which I am convinced resulted from my leg length discrepancy and hope that will relieve some or all of the back pain
        But it is obvious to me that this Conformis knee was not sized properly or angulated to match the other knee which has a slight knock knee . The Conformis knee is pencil straight and suggests the CT scan done pre-surgery was not effective in aiding the design From another comparative Leg Length CR scan done at the 18 month mark the Conformis knee is 1.2 cm longer than my unaffected leg This is obviously unacceptable and has basically ruined my quality of life
        I was better off before I had the TKR

  15. Well. been reading all the pro’s and con’s , have a appointment in oklahoma city Ok on 2/24/2022 with doctor West if iam a canadate for conformis. I do believe that a knee cloned to b near perfect to what God gave me would be the best choice. Iam 69 and have been putting this off for too long , but my spirit is so comforting on this particular knee that it’s got to b the fit for me , iam looking forward and will share results of my visit , God Bless all who have had it done , and the ones that r waiting

  16. Kathy did you finally find a doctor to help you? Getting lots of opinions and I am totally confused.

  17. I yes, Wolfgang, has a good reputation. Have to wait 6 months to get and appointment. I’m using Eric Smith at NEBH next Wednesday. He’s chief of arthoplasty, my second choice, he comes with a good reputation from his colleagues too. He’s done alot of conformis procedures.

    1. I am scheduled with Eric Smith in the fall for a TKR with Conformis. I am interested how Anthony’s surgery goes.

  18. why are less doctors using conformis knees? In NYC, there were several, now there is not one showing on the conformis website.
    regarding Kneeling, seems that the Stryker knee has less chance than the conformis of allowing kneeling.
    i welcome any feedback

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