PATIENT INFORMATION

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Creative and Innovative Spine Technology from NuVasive® | Minimally Disruptive Spine Surgery | Why Is This Procedure Performed? | What to Expect During the XLIF Procedure | Neuromonitoring During Surgery | Potential Risks | Recovery

Creative and Innovative Spine Technology from NuVasive®

NuVasive® is best known for its development of the XLIF® procedure. The XLIF approach is a minimally disruptive procedure that allows the spine surgeon to have direct access to the intervertebral disc space and fuse the lumbar (low back) spine from the side of the body (lateral) as opposed to the front (anterior) or back (posterior).

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Minimally Disruptive Spine Surgery

The XLIF procedure is what is termed a “minimally disruptive” procedure. This means that instead of a traditional, large, “open” incision, the procedure is performed through one or more small incisions. An instrument, known as a retractor, is used to spread the tissues so that the surgeon can see the spine.

Before the advent of minimally disruptive spine surgery, the spine generally had to be reached through one large incision in the front or back of the body. The advent of minimally disruptive spine surgery allowed surgeons to reach the spine through small incisions (as opposed to a single, large incision). Minimally disruptive surgery is thought to be better for many reasons, including: less tissue trauma, less scarring, shorter hospital stay, and less postoperative discomfort, thereby affording a decreased need for postoperative pain medication.

Like all minimally disruptive spine surgery techniques, the XLIF procedure was developed from the need to treat disorders of the spine with the least amount of tissue (muscles, ligaments, blood vessels, and abdominal organs) disruption possible, so that there is minimal tissue-related damage from the surgery, and the recovery time is therefore reduced.

The XLIF procedure is an innovative technique because not only is it minimally disruptive, but also it allows the surgeon to access the spine from the side of the body, which inherently means less soft tissue to have to traverse to get to the spine.

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Why Is This Procedure Performed?

The XLIF® minimally disruptive procedure can be performed for a number of situations. The list below contains representative examples. The list is not intended to include all possible indications and/or contraindications.

Any thoracolumbar case above L5-S1 requiring access to the disc space and/or vertebral bodies. Examples include:

  • DDD with Instability
  • Recurrent Disc Herniation
  • Degenerative Spondylolisthesis (≤ grade 2)
  • Degenerative Scoliosis
  • Pseudoarthrosis
  • Discitis, Vertebral Osteomyelitis (without active infection)
  • TDR Revision
  • Post-Laminectomy Instability
  • Junctional Disease

A special benefit of the XLIF approach is that it gives the surgeon access to the spine through the side of the body, thereby avoiding the major muscle groups in the back, and the major organs and blood vessels in the abdomen.

There are a few specific instances where the XLIF procedure cannot be performed. These instances include: some deformities with significant rotation, high-grade spondylolisthesis, and bilateral retroperitoneal scarring (from a prior abscess or abdominal surgery). Additionally, the XLIF procedure cannot be performed on the disc between the 5th lumbar and 1st sacral vertebrae.

Not everyone may be a good candidate for the XLIF procedure. Each patient should be treated individually, and a discussion of suitability should take place between patient and physician, as with any surgery.

Despite it’s advantages, your physician may decide that the XLIF procedure is not the most appropriate approach for you. Any generally accepted contraindication to fusion include the following:

  • Systemic infection
  • Osteoporosis
  • Significant co-morbidities
  • L5-S1
  • Lumbar deformities with > 30° rotation
  • Degenerative spondylolisthesis > grade 3
  • Bilateral retroperitoneal scarring (e.g., abscess or prior surgery)
  • Need for direct posterior decompression through same approach (Second posterior micro-decompression not contraindicated)

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What to Expect During the XLIF Procedure

First, the surgeon will position the patient so that the patient is lying on his or her side. Then the surgeon will use x-rays to locate the disc that is going to be removed. Once the disc is located, the surgeon will mark the skin with a marker directly above the disc. Then the surgeon will make a very small incision (cut) in the flank (low back region of the trunk), and use his or her finger to push away the peritoneum (sac covering the abdominal organs) from the abdominal wall.

The surgeon will make a second incision directly on the side of the patient. The surgeon will then insert a tube-like instrument, known as a dilator, into this incision. The surgeon will use x-rays to make sure that this dilator is in a good position above the disc. The surgeon will then insert a special probe (blunt tool) through a muscle known as the psoas muscle — a large muscle that runs from the lower (lumbar) spine, wrapping around the pelvic area and attached to the hip. Neuromonitoring, testing of the nerves during surgery to make sure they are not harmed or irritated during the process, is a critical part of this procedure. Because nerves exiting the spinal column are close to this muscle and can even run right over the surface of the psoas muscle, it is critical that the surgeon be provided with real-time information about the position of the nerves relative to his instruments. The neuromonitoring system used with the XLIF procedure (NeuroVision® by NuVasive,® Inc.) achieves this. The NeuroVision probe is designed to detect the position of the nerves, so that they are not disturbed during surgery.

Once the muscles are split apart, a special tool known as a retractor (MaXcess® by NuVasive, Inc.) is put into place to give the surgeon direct access to the spine. Once this direct access is achieved, the surgeon is able to perform a standard discectomy (intervertebral disc removal) with special tools designed to cut and remove the disc. Once the disc material is removed, the surgeon is able to insert the implant through the same lateral incision. This spacer (cage) will help hold the vertebrae in the proper position to make sure the disc height (space between adjacent vertebral bodies) is correct and the spine is properly aligned. This spacer (CoRoent® XL by NuVasive, Inc.), together with the bone graft, will allow the spine to fuse. The surgeon will take an x-ray to make sure the spacer is in the right position.

Sometimes, depending on the diagnosis of the patient, additional support is needed to hold the vertebrae in place. In this case, the surgeon may also decide to put in additional implants, such as screws, plates, or rods. A single-level XLIF procedure takes approximately one hour to perform.

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Neuromonitoring During Surgery

During the XLIF procedure, it is important to protect the nerves exiting the spinal column. This is true for any spine surgery. There is a special nerve monitoring system used during the XLIF procedure to make sure the nerves are functioning correctly. This NeuroVision system gives the surgeon real-time feedback. This type of nerve monitoring is known as electromyography or EMG. The EMG gives continuous neurophysiologic information about the specific nerve roots or groups of nerves that are near the psoas muscle and exiting out of the vertebral level(s) being operated on. This intraoperative information about your nerves helps the surgeon make the safest choices during surgery.

Indications for Use The NeuroVision® System is intended for use in the operating room and non-critical care clinical environment for neurological monitoring and status assessment. The System may be used alone or in conjunction with other NuVasive devices to assist in gaining controlled access to the spine.

It is important that you discuss the potential risks, complications, and benefits of the NeuroVision System with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

Talk to your doctor to learn more about the NeuroVision System. Or, use the Physician Locator on www.lateralaccess.org to search for a SOLAS surgeon in your local area.

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Potential Risks

The eXtreme Lateral Interbody Fusion (XLIF) procedure, like any other surgical procedure, is not without risks. Risks specific to any lumbar spinal surgery include, but are not limited to: revision or reoperation, change in lordosis, injuries to kidneys or ureters, deterioration in neurological status, facet joint deterioration, spondylolysis, spondylosis, spondylolisthesis, nerve damage due to surgical trauma, neurological difficulties including bowel and/or bladder dysfunction, retrograde ejaculation, tethering of nerves in scar tissue, muscle weakness or paresthesia, vascular damage including hematoma, ileus injuries, deep vein thrombosis potentially leading to pulmonary embolism, catastrophic or fatal bleeding, dural tears experienced during surgery resulting in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis, bursitis, paralysis, damage to lymphatic vessels and/or lymphatic fluid exudation, fracture of bony structures, anesthetic reaction, bowel perforation, hernia, infection-peritonitis, periotoneal adhesions, failure of the procedure to improve symptoms and/or functions, spinal stenosis, and death.

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Recovery

The XLIF® procedure is a surgery from which patients generally recover easily. The length of time the patient is required to stay in the hospital after surgery varies according to the individual; however, many patients are able to go home from the hospital a day or two after surgery.

Many patients notice a difference in their preoperative symptoms (i.e., leg pain, etc.) immediately after surgery. In other patients, preoperative symptoms often go away gradually. Pain at the incision sites after surgery is normal and should be expected. This pain should eventually go away and should be easily controlled with oral pain medication that is prescribed upon discharge from the hospital. Because the surgery does not cut muscles, but rather only splits them, many patients are able to get up and walk around the night after they have had surgery.

The total average time spent in the hospital postoperatively depends on the number of vertebral levels that were fused and the problem that was being addressed. Some patients are able to undergo an XLIF procedure on an outpatient basis; others require a stay of a few days or a week in the hospital.

Total recovery time is relatively short, and most patients are able to return to their normal activities within a few months of surgery.

Hospital Stay - 1-2 days with XLIF. 3-5 days with traditional surgery.
Graph Hospital

Walking - Same day with XLIF. 2-4 days with traditional surgery.
Graph Walking

Return to Normal Activities - 4-6 weeks with XLIF. 6 months or longer with traditional surgery.
Graph Recovery

Blood Loss - Less than 100cc with XLIF. 300-600cc with traditional surgery.
Graph Blood

Risks specific to any lumbar spinal surgery include, but are not limited to: revision or reoperation, change in lordosis, injuries to kidneys or ureters, deterioration in neurological status, facet joint deterioration, spondylolysis, spondylosis, spondylolisthesis, nerve damage due to surgical trauma, neurological difficulties including bowel and/or bladder dysfunction, retrograde ejaculation, tethering of nerves in scar tissue, muscle weakness or paresthesia, vascular damage including hematoma, ileus injuries, deep vein thrombosis potentially leading to pulmonary embolism, catastrophic or fatal bleeding, dural tears experienced during surgery resulting in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis, bursitis, paralysis, damage to lymphatic vessels and/or lymphatic fluid exudation, fracture of bony structures, anesthetic reaction, bowel perforation, hernia, infection-peritonitis, periotoneal adhesions, failure of the procedure to improve symptoms and/or functions, spinal stenosis, and death.

The XLIF® minimally disruptive procedure can be performed for a number of situations. The list below contains representative examples. The list is not intended to include all possible indications and/or contraindications.

Any thoracolumbar case above L5-S1 requiring access to the disc space and/or vertebral bodies. Examples include:

  • DDD with Instability
  • Recurrent Disc Herniation
  • Degenerative Spondylolisthesis (≤ grade 2)
  • Degenerative Scoliosis
  • Pseudarthrosis
  • Discitis, Vertebral Osteomyelitis (without active infection)
  • TDR Revision
  • Post-Laminectomy Instability
  • Junctional Disease

Any generally accepted contraindication to fusion, such as:

  • Systemic infection
  • Osteoporosis
  • Significant co-morbidities
  • L5-S1
  • Lumbar deformities with > 30° rotation
  • Degenerative spondylolisthesis > grade 3
  • Bilateral retroperitoneal scarring (e.g., abscess or prior surgery)
  • Need for direct posterior decompression through same approach
    (Second posterior micro-decompression not contraindicated)

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It is important that you discuss the potential risks, complications, and benefits of XLIF ® with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.

For additional information on XLIF, please visit www.xlif.com and www.lateralaccess.org and www.thebetterwayback.org.

Nate “Rock” Quarry is a paid spokesperson for NuVasive®, Inc.