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What is the X-STOP® Device?
The X-STOP® is a titanium metal implant designed to fit between the spinous processes of the vertebrae in your lower back. It is designed to remain safely and permanently in place without attaching to the bone or ligaments in your back.
The oval spacer fits between the spinous processes and the wings are designed to prevent the implant from moving.
Patients can gain relief from chronic lower back pain, and may walk out of the hospital the same day, thanks to this innovative new surgical implant that recently was approved by the FDA.
The X-STOP® Interspinous Process Decompression System implant is inserted through a small incision in a patient's back. It separates the ligaments and bone, which prevents pressure on nerves and immediately relieves pain. The procedure takes less than one hour and typically requires a local anesthetic. Many patients are able to stand upright and walk the same day of the surgery.
[Please note: The X-STOP® implant is manufactured from a titanium alloy of metal. Please inform your doctor if you think you are allergic to titanium or titanium alloy. It is also known to produce artifacts if you undergo an MRI exam. If you have an MRI exam, after you have had X-STOP® surgery, inform your doctor that you have the X-STOP®.] Failure to inform your doctor may affect the quality of diagnostic information obtained from these scans. The X-STOP® is MRI safe.
What What is IPD®?
Interspinous Process Decompression (IPD) is a surgical procedure in which an implant, called the X-STOP®, is placed between two bones called spinous processes in the back of your spine. With IPD surgery or X-STOP® spinal stenosis surgery there is no removal of bone or soft tissue. The X-STOP® implant is not positioned close to nerves or the spinal cord, but rather behind the spinal cord between the bony spinous process.
How is the X-STOP® procedure performed?
Using local anesthesia and with the help of X-ray guidance,the X-STOP® Interspinous Process Decompression System implant is inserted through a small incision in a patient's back.
Alternatively, your surgeon may elect to use general anesthesia. It separates the ligaments and bone, which prevents pressure on nerves and immediately relieves pain. The procedure takes less than one hour and typically requires a local anesthetic. Many patients are able to stand upright and walk the same day of the surgery. |
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Specialized spinal surgeons perform this procedure, which is just one of the minimally invasive surgical treatments available for back and spinal conditions. Minimally invasive techniques are performed whenever possible so that patients can benefit from smaller incisions, faster recovery and less post-operative pain.
You will be placed on your side during the procedure so that you can bend your spine when the X-STOP® is inserted. The surgery to implant the X-STOP® typically lasts 45 minutes to an hour-and-a-half. During this time you may be awake and able to communicate with your doctor.
Patients may experience rapid relief from their symptoms and enjoy improvement of physical function. The unique design of the X-STOP® implant enables it to be inserted using a minimally invasive approach, resulting in very little tissue disruption. Also, the X-STOP® implant's unique design allows it to be implanted without fixation to bones or ligaments so to provide a reversible procedure that should not limit future treatment options. Due to its minimally invasive nature, the procedure can typically be performed in less than an hour, and as demonstrated during the clinical trial, with a low rate of procedural complications.
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Am I a candidate for X-STOP® spinal surgery?
You may be a candidate for the X-STOP® spinal surgery if you have primarily leg pain rather than mostly back pain and your pain is due to spinal stenosis/ foraminol stenosis. Your leg pain is worse with prolonged standing and bending backwards. You must get significant relief of your pain when you sit down and bend forward or stand and bend forward.
According to an independent market research organization, there are approximately 1.4 million individuals in the United States with a primary or secondary diagnosis of lumbar spinal stenosis. The X-STOP® device may be a treatment alternative for approximately 220,000 of these individuals who would have otherwise been treated with conservative non-operative therapies or with a surgical procedure called a laminectomy.
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What are the benefits to being treated with the X-STOP® IPD®?
IPD offers several benefits compared to traditional surgery for lumbar spinal stenosis, including:
- the option of local anesthesia
- the potential to be an outpatient procedure (often walking out of the hospital on the same day as surgery)
- usually no removal of bone or soft tissue allowing for potentially quicker recovery
- fully reversible procedure that does not limit any future non-surgical and surgical treatment options
- the implant can be removed
- virtually no chance of dural tear or neurologic complication
- does not create instability
- insignificant blood loss
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X-STOP® IPD®: Clinical Study Results
The X-STOP® IPD System was tested in a carefully controlled research study that took place in nine hospitals across the United States. In this study, 100 patients with lumbar spinal stenosis had x-stop spinal surgery with the X-STOP® device. These patients were compared to 91 patients who did not have surgery, but were treated by their doctors in other ways (for example, with medications, corsets, physical therapy, etc.).
Approximately half of the patients who received the X-STOP® device in this two-year research study experienced a degree of pain relief and ability to increase their activity levels that was sufficient to be considered a successful outcome at two years after the surgery. The clinical benefit beyond two years has not been measured.
The likelihood of needing an additional operation during the study was low. Overall, 90% of patients had significant improved clinical outcome.
Read about a patients experience with the X-STOP®: X Marks the Spot For A Los Angeles Transportation Supervisor
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