Product FAQ

  1. How is sacroiliac joint fixation / fusion accomplished?
  2. Who can have the procedure using the iFuse Implant SystemTM?
  3. How will my doctor determine whether I am a candidate for the iFuse Implant SystemTM?
  4. What is the procedure for iFuseTM?
  5. What are the iFuseTM implants made of?
  6. How do the iFuse ImplantsTM work?
  7. What makes the iFuseTM implants different from other fusion devices?
  8. How long does the operation take?
  9. What happens after my iFuseTM procedure?
  10. How soon can I resume my daily activities?
  11. If I have already had one or more spinal fusions, does this affect my ability to have a sacroiliac joint fusion?
  12. If I have an iFuse ImplantTM procedure, does it affect my ability to have other surgeries if I need them?
  13. Could there be complications from the iFuseTM procedure?

1. How is sacroiliac joint fixation / fusion accomplished?

Traditional sacroiliac joint fixation/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.

Now there is a less invasive procedure available for fixing the Sacroiliac (SI) Joint, the iFuseTM Implant System. This less invasive procedure requires a smaller incision, uses a guide pin, and places two or more titanium implants across the sacroiliac joint. These small implants are designed to fix the Sacroiliac (SI) Joint and allow stable healing through minimization of micromotion.

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2. Who can have the procedure using the iFuse Implant SystemTM?

The procedure using the iFuse Implant SystemTM is suitable for treating sacroiliac joint conditions; these may include injuries or chronic conditions. The procedure has been used successfully in patients with such conditions including patients who were injured in a fall, with back pain after pregnancy, or job-related repetitive stress injuries.

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3. How will my doctor determine whether I am a candidate for the iFuse Implant SystemTM?

Once the source of your low back pain has been diagnosed as sacroiliac joint in origin, your surgeon will discuss the iFuse Implant SystemTM procedure as a potential intervention with you.

You may be an iFuseTM 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.

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4. What is the procedure for iFuseTM?

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 ImplantTM, and supporting instrumentation are designed to offer maximum protection to your tissues and minimize soft tissue exposure during the surgical procedure.

The entire procedure is performed through a small incision (approximately two inches), along the side of your buttock. During the procedure, fluoroscopic imaging provides your surgeon with live imaging to facilitate proper placement of the implants. Typically, two to four rods are placed, depending on your size.

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5. What are the iFuseTM implants made of?

The iFuse ImplantsTM 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.

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6. How do the iFuse ImplantsTM work?

The iFuse ImplantsTM 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 latticed structure on the surface of the implants, which is designed to create an interference fit to bone. This helps to better secure the iFuse ImplantsTM to bone. The stiffness of the implants holds the joint in place.

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7. What makes the iFuseTM implants different from other fusion devices?

In contrast to the placement of screws across the sacroiliac joint, the iFuse ImplantsTM are designed to maintain their implant position over time. Regardless of the fixation implants used, there are two separate fusion mechanisms that fix the Sacroiliac (SI) Joint over the long run - intra-articular fusion that occurs across the joint and extra-articular fusion due to the stiffness of the implants. The iFuse ImplantsTM are designed to firmly fix the joint.

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8. How long does the operation take?

Typically, iFuseTM surgery takes about an hour, and usually a CT scan is done after surgery, to help verify the position of the implants.

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9. What happens after my iFuseTM procedure?

At discharge, your doctor may arrange follow-up visits to assess the incision and take follow-up X-rays. You will need to use either crutches or other assist devices are recommended for up to 12 weeks. Avoid all weight-bearing activities on the fused side for at least 6 weeks to allow proper healing. After that, with your doctor’s okay, you can start partial weight-bearing activities for another 6 weeks. After a minimum of 3 months post-surgical healing, your doctor may have you come back for more X-rays and, barring any complications per your doctor’s assessment, you may resume full weight-bearing activities.

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10. How soon can I resume my daily activities?

Your doctor will advise you on resuming your daily living activities as your healing and symptoms allow. Depending on your occupation, you may be able to return to work at this time. You will need to have additional X-rays taken at 6 months and later at 1 year in order to assess your progress.

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11. If I have already had one or more spinal fusions, does this affect my ability to have a sacroiliac joint fusion?

The iFuseTM may be safely used in patients with previous orthopedic surgeries and spinal implants. Sacroiliac joint problems may coexist with lumbar spine or hip conditions. Sacroiliac pain may appear after lumbar spine surgery or hip replacements. The iFuseTM can be safely used after either lumber or hip surgeries or both.

Your doctor will determine whether your health, including any impact from previous surgeries, influences your being a candidate for sacroiliac joint fusion.

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12. If I have an iFuse ImplantTM procedure, does it affect my ability to have other surgeries if I need them?

In some cases, a person may require other surgeries after having an iFuse procedure. The iFuse ImplantsTM are not anticipated to affect the ability to have other surgeries.

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13. Could there be complications from the iFuseTM procedure?

Major complications from this procedure are rare, 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. This greatly lessens the risk of infection.

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SI-BONETM and iFuse Implant SystemTM are trademarks of SI-BONE, Inc.
An Advanced Approach to Surgical Management of SI Joint Dysfunction
Up to 25% of all low back pain is SI Joint in origin – but the diagnosis of SI Joint disease is frequently overlooked. (Cohen, et al.)
It is common to link low back pain with protruding disc even when neurological signs are absent. (Weksler, et al.)
It is common for pain from SI Joint dysfunction to mimic discogenic or radicular low back pain. (Weksler, et al.)
Many patients go on to receive lumbar fusion instead of SI Joint fusion – so SI Joint disease should be strongly considered in differential diagnosis of low back pain. (Weksler, et al.)
Now there is an approach to surgical management of SI Joint dysfunction that’s easier and less invasive than traditional open surgery.
The iFuse Implant System consists of porous plasma spray coated implants, surgically inserted across the SI Joint to create fixation leading to fusion—from the inside.
The iFuse creates a biomechanically rigorous fixation/fusion system, designed to support reliable fixation/fusion and acute weight bearing capacity.
With the iFuse Implant System, there is no need for BMP in conjunction with autologous bone graft or additional pedicle screws, rods or hollow modular anchorage screws or cannulated compression screws or threaded cages within the joint or fracture fixation screws.
iFuse benefits:
The iFuse Implant System is designed to be the sacroiliac joint fusion/fixation method of choice for spine surgeons.
iFuse is a minimally invasive surgical solution to replace open surgical SI Joint fusion.
With iFuse there's minimal incision size, minimal soft tissue stripping, minimal tendon irritation and reduced risk of infection.
iFuse is a simplified minimally invasive surgical procedure.
Just drill, broach, insert Implants and close.
iFuse has a simple technique which reduces OR time to less than 1 hour.
iFuse has 3X shear and 7X bending strength compared with screws.
iFuse has improved patient perception of stability post-implant.
The incidence of SI joint degeneration in patients was 75% at 5 years post-fusion, which was significantly higher than in the non-fusion group, 38.2%. (Ha, et al.)
Among patients with one-segment fusion, 91% developed SI joint degeneration. (Ha, et al.)
Regardless of whether the fusion includes the sacrum, the SI joint is influenced by increased mechanical stress arising from lumbar/lumbosacral fusion. (Ha, et al.)
Posterolateral lumbar/lumbosacral fusion can be a cause of SIJ degeneration. (Ha, et al.)