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Q. How are traditional and MIS sacroiliac joint fusion done?
A. Traditional sacroiliac joint fusion involves open surgery that may last up to several hours. Open surgery includes a significant incision to access the joint, removal of cortical tissue from the joint and use of bone grafts from another part of your body to help fuse the joint. Patients typically require a several day hospital stay. Alternatively, the minimally invasive surgical (MIS) iFuse Implant System® is now available. This MIS procedure requires a smaller incision and uses a guide pin to place the titanium implants across the sacroiliac joint. These small implants are designed to fix the sacroiliac (SI) joint and allow stabilization and healing through minimization of micromotion. Typically three iFuse Implants are used in an iFuse procedure.
Q. How will my doctor determine whether I am a candidate for the iFuse Implant System?
A. Once the source of your low back pain has been diagnosed as SI joint in origin, your surgeon will discuss the iFuse Implant System procedure as a potential intervention with you. You may be an iFuse surgical candidate if your low back symptoms are predominantly below your L5 vertebra, your doctor does not find any neurological problems, and is able to determine through maneuvering your joint that your pain originates in the sacroiliac joint. To confirm your diagnosis, your doctor may administer a CT guided injection of pain reducing medication to your sacroiliac joint and verify that you experience significant pain relief from it. Some doctors may repeat the injection to be sure.
Q. What is the procedure for iFuse?
A. The iFuse Implant System® is used in a surgical procedure that is performed in an operating room with either general or spinal anesthesia. You will be lying face down while your surgeon uses the specially designed system to guide the instruments that prepare the bone and insert the implants. The surgical technique, iFuse Implant, and supporting instrumentation are designed to offer maximum protection to your tissues during the surgical procedure. The entire procedure is performed through a small incision (approximately 2-3cm long), along the side of your buttock. During the procedure, X-ray guidance provides your surgeon with live imaging to facilitate proper placement of the implants. Typically three implants are placed, depending on your size.
Q. What are the iFuse Implants made of?
A. The iFuse Implants are small titanium rods about the size of your little finger. Titanium is a very strong but lightweight material, commonly used for medical device implants.
Q. How do the iFuse Implants work?
A. The iFuse Implants have triangular cross-sections to keep them from rotating once they have been implanted. They are also coated with a titanium plasma spray that creates a rough surface to better secure the iFuse implants to bone. The implants are strong and provide stability to the joint.
Q. What makes the iFuse Implants different from other fusion devices?
A. The iFuse implants are designed have a unique triangular shaped design to maintain their implant position over time and to firmly fuse the joint.
Q. What happens after my iFuse procedure?
A. Your doctor will most likely recommend post-operatively using crutches, a cane or a walker for 3 to 6 weeks. To minimize the low risk of blood clots in your legs, you should not travel by air for at least 2 weeks after an iFuse surgery. It is also recommended that you see your surgeon for a post-operative visit between 1 and 2 weeks following surgery to assess the incision and for follow-up X-rays. Based upon your doctor’s recommendation, you will also see your doctor approximately 12 weeks post-surgery for more X-rays and to determine whether you may resume full weight-bearing activities.
Q. What can I do to avoid problems healing after iFuse surgery?
A. Your doctor will provide you with post-operative instructions. In general, you should avoid strenuous activities in the first six weeks and follow your surgeon’s post-operative weight bearing and activity instructions. Avoid smoking, which is thought to impair bone fusion. Discuss your current medications with your surgeon; some medications may impair bone growth (for example: steroids). If you have osteoporosis, ask your doctor what osteoporosis medications might be best for your bone health. [References: (Fusion versus nonoperative management for chronic low back pain: do comorbid diseases or general health factors affect outcome? http://www.ncbi.nlm.nih.gov/pubmed/21897346 ) (Dose-dependent inhibition of diclofenac sodium on posterior lumbar interbody fusion rates. http://www.ncbi.nlm.nih.gov/pubmed/18790686 )
Q. How soon can I resume my daily activities?
A. Your doctor will advise you on resuming your daily living activities and return to work as your healing and symptoms allow. You will have additional X-rays taken at 6 months and later at 1 year to monitor your progress.
Q. If I have already had one or more spinal surgeries, does this affect my ability to have MIS sacroiliac joint surgery?
A. The iFuse may be used in patients with previous orthopedic surgeries and spinal implants. SI joint problems may coexist with lumbar spine or hip conditions. SI problems may appear after lumbar spine surgery or hip replacements. The iFuse can be safely used after either lumbar or hip surgeries or both. Your doctor will determine whether your health, including any impact from previous surgeries, influences your being a candidate for MIS sacroiliac joint fusion.
Q. If I have an iFuse Implant procedure, does it affect my ability to have other surgeries if I need them?
A. In some cases, a person may require other surgeries after having an iFuse procedure. The iFuse Implants are not anticipated to affect the ability to have other surgeries.
Q. Could there be complications from the iFuse procedure?
A. Major complications from this procedure appear to be uncommon, but like any surgery you may undergo, there are always some risks. Postoperative bruising and local swelling are part of the expected surgical recovery. One example of a major complication that may occur is infection. Infection may happen with any interventional procedure. This is why antibiotics are typically used both before and after surgery to lessen the risk of infection.
Q. Can the iFuse Implant be removed or revised?
A. Although infrequent, there may be a reason (e.g. malpositioning, loosening, trauma, etc.) an iFuse Implant may need to be repositioned or removed. The determination to remove an implant will be based on the treating physician’s best judgement. SI-BONE has developed a detailed algorithm to assist the surgeon with this decision and to guide the physician through the revision procedure.
Q. Is a pre-operative manual adjustment of the sacroiliac joint necessary to achieve successful iFuse results?
A. SI-BONE has received a number of inquiries related to manually adjusting and aligning the sacroiliac joint on the day of surgery, before the iFuse procedure is performed. In response to these inquiries, SI-BONE polled a number of surgeons who perform the iFuse procedure. It was determined that there is currently no consensus as to which manual alignment procedure is best, or if pre-operative alignment is even necessary to achieve successful results. In addition, there are currently no peer-reviewed publications that address the pros and cons of pre-operative adjustment and its effect on patient outcomes. Until such data is available, if you wish please discuss this issue with your surgeon as he or she is in the best position to determine your optimal treatment.