Tuesday, May 18, 2010

IPod, IPhone, ITouch, IFuse, IPad

Recently, one of our readers expressed interest in a company by the name of IFuse, asking the question, is this a viable procedure? In the interest of developing some dialogue amongst our readers, and providing this company some visibility, TSB must ask our readers, is there a place for this device in the surgeon's armamentarium, or, is this another product that is looking to expand on an already limited but existing market?

From a historical perspective, orthopaedic surgeons have been performing percutaneous iliosacral screw fixation for years, especially in trauma. Because of the potential for soft tissue complications with open posterior exposures, the concept of limiting the amount of surgical dissection for fusion and fixation has become popular. Since this procedure (IFuse) is performed percutaneously a thorough understanding of the sacral radiographic anatomy is demanded. Why? Because there is no chance to guide or confirm implant placement by direct palpation or direct visualization. Three major structures are at risk of injury whenever using a guide wire, drill bit or implant, these include the iliac artery, the superior artery and the S1 root canals and their foramina.

Based on the biomechanical testing, this implant provides the surgeon with an implant that can withstand greater bending and shear loads than traditional cannulated screws. So in the spirit of debate, is there a place for this product or is this another one of those one-trick pony's looking for a procedure, or, is this another one of those implants that can be used to stage a patient to ultimate posterior fusion?

Maybe, SI Bone can hook up with Apple and make the IFuse Surgical Technique an application on the IPhone? It would save the company the headache of developing a distribution network and the cost of sales? Could this be the future? I think I will call Steve Jobs.

26 comments:

  1. Supposedly a lot of surgeons are using the procedure in Las Vegas. Go figure. Interested to see what the verdict is on it.
    Thanks

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  2. The peer-reviewed outcomes on SI fusion for pain relief are very poor. We have a prime example of another technology that will increase utilization (by surgeons and pain docs), garner a lot of industry interest (primarily because of the names behind the product), while not solving a clinical problem. Sounds like another product that while lucrative in the end wont improve care for spine patients. By the way, was the post cut-and-pasted straight out of the companies propoganda...sorry, educational materials?

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  3. I have observed this procedure. Aside from the inherent difficulties of needing two c-arms in the room simultaneously, the ability to visulaize in 3-D and work in multiple planes is taxing at best. In this case it was a learning curve approaching vertical for the surgeons. Although if the implants are placed correctly it would seem to be a sound construct.

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  4. Spine gypsy-- are you a doc or industry rep? how did you observe the procedure?

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  5. I observed my first case a week ago. It was not performed by a Spine Surgeon, but by a Trauma trained General Orthopedic Surgeon. Agreed that with any new technology there will be those that treat it as the proverbial hammer, but as a tenured sales professional with over a decade in this business, I know when a product in the right hands can make a difference, and this is definitely one. There are patients that suffer ongoing pain from the instability of this joint. I dare say more than a few Spine fusion patients have undergone unnessary surgery because the symptoms for LBP and SI Joint Pain cross-over. As for the learning curve, the success or failure ANY procedure in the MIS platform is dependent on good imaging and a surgeon who is comfortable with the anatomy he sees on the screen. There are specific safety zones that every surgeon must stay in, regardless of product.

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  6. tx for your reponse. i agree that this procedure when done for the correctly chosen pt, by a well trained surgeon may make a difference for someone that has suffered SIJ dysfunction for a long time.

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  7. But the real question is whether this device is intended for a spine surgeon or is it intended for a pelvic surgeon? Or possibly both. Where's Joel Matta when you need him?

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  8. musculoskeletal man: I sent you comment re: SIJ treatment- did you not get it or preferred not to post it?

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  9. am a Board Certified/Spine Fellowship trained Orthopedic surgeon. The discussion about Sacroiliac Joint treatment is very important, and I am thrilled that there is open and public exchange of information.

    The prevalence of SIJ pain is very underestimated by the medical community; diagnosis is frequently confused among many different Pain Generators causing Low Back Pain; treatments are frequently provided by pain managment practitioners; often patients are treated for problems that resemble SIJD, but the approach is likely to fail because of inaccurate work-up and diagnosis.

    The literature supports the incidence of SIJ dysfunction as anywhere between 10 to 25% of patients with LBP. Diagnosis is missed because a practitioner is not looking for the condition, or may not believe the SI is a legitimate source of LBP.

    For those pts. for whom the diagnosis is established, there is a long list of treatment options, many are within the category of non-operative. Many pts are successfully managed, some will have either complete or partial improvement; some will have recurrent symptoms but not interfering with activities of daily living. For the unfortunate, Nonop does not help much, and their lifestyle is significantly affected. For these pts, a surgical option may be a reasonable choice.

    Until recently ( the last 2 years or so) surgical treatments utilize "open" techniques with a wide variety of combinations of Bone Graft/screw fixation/cage placement/plate and screws/ screws and rods. These open procedures are lengthy, require hospitalization, have blood loss and post op pain issues.

    In an effort to address the inconveniences of the open techniques, and utilize the current technologies available to surgeons, a less invasive approach was developed. Using proven implant technology that permits longterm stability between implant and bone, and imaging the allows for accurate placement, a small incision and minimal soft tissue disruption with less blood loss, gives pts the opportunity for stabilization of the SIJ with the expectation of symptom relief. This approach utilizes triangular Titanium implants through a 3 cm incision. Most pts are same-day-surgery.

    The iFuse implants are placed using specially designed instruments for accurate surgery. SI-Bone is the company that developed the procedure and instruments. The implants have a long and strong track record in applications elswhere.

    Surgical outcomes for this procedure are being evaluated by several centers, and data will be published. The literature already has articles that show successful outcomes with open techniques. As with any surgery, proper pt selection and adherence to good technique will provide for good to excellent patient outcomes.

    My personal experience with 45 cases, has an 82% pt satisfaction: when asked "did you get sufficient symptom improvement that you would do the procedure again", most said yes. For the 4-5 pts for whom the answer was no, the explanations lie in either unrealistic pt expectation or my indication was not precise.

    There is a need to offer pts with severe-longstanding SIJ problems a permanent solution using current technology and less invasive approach.
    I put my reputation and skill set on the line: of the pts I have treated, one is a nurse and another is an xray tech at my hospital that I work with every day! They are among many for whom the longstanding debilitating SIJ dysfunction was very successfully managed.
    They and I are pleased that is was accomplished using the less invasive approach. I have treated one of the ER docs and a Pulmonologist: my peers have told me that the surgery made a big difference in their life.

    It is time to get the focus of discussion away from industry and onto better patient care through proper diagnosis and state of the art treatment options.

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    1. I just had this surgery on Oct 28, 2013, 8 years I have lived in pain and I slept in a bed my second day wih only surgical pain, I can't wait to see the outcome.

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  10. Great Response LR!! What is your treatment algorithm before you would use the above mentioned problem? I have tried to bring the condition and product up to a couple of my surgeons but the response I got was luke warm at best. It seems that they don't really think SIJ pain can be fixed or treated with the SI Boen product.
    Thank you!

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  11. Well, I am living in Australia, am 30 and have been severely disabled for 8 years, struggling to work and study an eventually just spending my days lying with my feet up at my parents home taking lyrica, valium, ibuprofen and other drugs.
    I can't sit down without feeling like my back from hamstring to lower thoracic spine is being ripped apart by a knife and set on fire with chronic muscle contractions, which no doubt are a secondary si joint stabilisation mechanism.
    Diagnosis for this condition, at least in Australia, is shit! And it sounds like similar willful blindness to the condition permeates the US medical practice too.
    I have been treated as a musculoligamental pain patient (where I made physios happily pedaling their pseudo science quite wealthy and contributed to my own progressive impoverishment) , MS sufferer, fibromyalgia sufferer, neuropathic pain sufferer, anxiety patient and more.
    This condition is real!!! It does not appear on a whole spine mri and I was regarded in a very rude manner by many doctors who I consulted over eight years. It was my own study which allowed me to discover the solution and the correct diagnostice tests SI joint injections of steroids, anesthetic and contrast. My best response to a bilateral injection was 95-100% RESOLution of pain for a few days.
    One more point, I know that undiagnosed patients with the severe cases are going through hell and are certainly eventually choosing suicide to resolve the debilitating pain and the stigma of being 'a bit funny in the head'.
    My fall was in 2002 on a one time only snowboarding accident where I slammed into the ice on my buttocks at about 50km per hour while I hear a loud bang through the spine.
    Risking this surgery is something I must do and I wish to hear from people who have already had iFuse.
    I will come to the USA to obtain iFuse as soon as I can! the risk of failure is basically that I end up with debilitating pain lying around my parents house with my feet up - the situation I am already in!
    I am primarily concerned about the fact that fixation of the joints removes the small natural si joint movement and the important shock absorbing capacity of the joint. Hopefully in the future a shock absorbing component/small movement component should be built into the joint! Creating an equal or enhanced artificial si joint.
    Please people who have already had the operation post your experience!

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    1. I had the procedure on August 6, 2012. I was up and walking on my own an hour after I got to my room. I spend the night at the hospital just as a precaution and was released first thing the next morning. As far as pain, incision pain but that was gone within a week and muscle pain which has gotten lesser everyday. My post-op pain is nothing compared to the pain I was in before the surgery. I can walk a half a mile now where before walking to the mailbox was a problem. For the first two weeks - no bending, no lifting anything over 10 pounds and no twisting. Other then loading the dishwasher and getting my dogs fresh water I've been able to take care of myself. Doing everything all by myself with the help of a pair of picker upper grabber things. Today at my 2 week post-op appointment all my restrictions were lifted. I was told that I could do anything. Just to be careful, go slow and let the pain be my guide. I'm actually happy for the first time since December 2010 when I had to take a medical leave of absence. I can't wait to get back to work and on with my life. I hope this was helpful and you are more then welcome to ask any question.

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    2. Hi
      Anon from Australia. Just reading your post..very delayed from your visit to this site ...but all the same wondering how you are and if any help or relief came? I can so very much relate to your story :-( Hope you see this post/reply

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  12. LR>?>?> Do you have articles on patient outcomes that have been operated on with the ifuse system?

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  13. I had the i-fuse implant surgery four weeks ago. I developed Sijd from a bone graft that was done during a long scoliosis fusion surgery. So far I am in agonizing pain. The surgeon put the implant too far into the neuroforamen and damaged the nerve. A shorter implant was inserted. The nerve pain is getting better, but the SI pain continues, except I am able to lie down and rest now. Before the surgery, if I did not keep moving, I developed such tightness, it could only be relieved by deep tissue massage from a therapist. The surgeon said I may not receive optimal relief from the surgery, because the long fusion puts so much pressure on the SI joint. At this point, I am hoping with time things will improve.

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  14. I am 3 weeks post-op using iFuse implants. According to the doc, the recovery time on crutches/walker has been shortened to 3 weeks. I have had three lumbar surgeries, the last was a fusion. This was my 4th in 3 and a half years and I have never experienced the instantaneous relief that this last surgery provided. I'm very grateful for the manufacturer's product and my surgeon's expertise!

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    1. I am 3 weeks post op Ifuse implants too. So far, so good. I still have muscle spasms from surgery but from what i can tell it was very successful! Thanking God for this healing through doctors procedures!

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  15. I am 33 yrs old 6 mos post op from my second lumbar fusion and now suffer from si dysfunction. I have tried everything from pt to prolotherapy with no relief in pain. I dread another surgery since i am young and i have yet to have children because of my back issues. I live in Maryland....how can i find a surgeon on the east coast who performs the iFuse.

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  16. First operation: SI screw fixation failed, screw loosing very soon.
    Second Operation: Open reduction (bone harvesting) and tightening of screws.
    Screws were removed because of severe pain.
    All done without manipulating the ligaments pre op.
    Third attempt: iFuse.
    6 weeks post op and abdominal pain and in butt, and the SI is blocked and the foot can not put on the floor, so walking not possible. when ligaments come loose again, all fine.
    Who knows, what can be done? It still unstable.
    What can be done??

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  17. I understand there are a few company manufacturers that have an SI fusion system. Who are all the SI fusion companies that are already FDA approved in the United States? Which is the best and why? Thanks.

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    1. SI Bone and Zyga Technology

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    2. And Globus and Signus also have systems.
      Nuvasive-Medtronic-K2 and Zimmer are all working on one.

      SI Bone just "downsized" employees (25%). So there will be plenty of expertise flowing to these companies.

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  18. I've had the procedure on both sides. My last one was in June, 2012. I felt great for the three weeks that I was on the crutches. The pain was gone the second day after surgery. Unfortunately, I'm having severe pain again in the SI. I'm so disappointed, I thought that I finally had my life back after being incapacitated for the past three years. Has anyone else had any problems post op?

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    1. Had both si joints done with the new Ifuse. One in August 2012 and April 2013. Not happy at all,cannot sit for any period of time and have major spasms in groin and difficulty walking. Also have a hot poker feeling in pelvis. Very disappointed.

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  19. I had ifuse on both sides. One in 2012 & one in 2013. I am doing great! The ifuse gave me my life back! I highly recommend it. I am even thinking of going back to work!

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