X-STOP: a newer treatment offering several benefits when compared to traditional surgery for lumbar spinal stenosis causing neurogenic claudication

The X-STOP® device 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.     

Interspinous Process Decompression (IPD®)

IPD is a surgical procedure in which an implant, called the X-STOP device, is placed between two bones called spinous processes in the back of your spine.

With IPD 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 processes.

The procedure may be performed in either the operating room or special procedures room at the hospital. Using local anesthesia and with the help of X-ray guidance, the X-STOP implant is inserted through a small incision in the skin of your back. Alternatively, your surgeon may elect to use general anesthesia.

You will be placed on your side during the procedure so that you can bend your spine when the X-STOP implant is inserted. The surgery to implant the X-STOP device typically lasts 45 minutes to an hour-and-a-half. During this time you may be awake and able to communicate with your doctor.

The X-STOP implant is designed to keep the space between your spinous processes open, so that when you stand upright the nerves in your back will not be pinched or cause pain. With the X-STOP implant in place, you should not need to bend forward to relieve your symptoms.

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

• 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

Are you a candidate for the X-STOP IPD procedure?

The X-STOP system is indicated for patients aged 50 or older who have lumbar spinal stenosis. A diagnosis of lumbar spinal stenosis should be confirmed by a doctor with X-ray, MRI or CT scans. The X-STOP system is indicated for patients with moderately impaired ability to function, who experience relief from their pain symptoms when bending forward. Patients receiving the X-STOP implant should have already been under a doctor’s care and getting non-surgical treatment for their symptoms for at least 6 months. The X-STOP implant may be implanted at one or two levels of the lumbar spine.

Who should not receive it?

The X-STOP system should not be used if you have:

• an allergy to titanium or titanium alloy

• spinal anatomy that would prevent implantation of the device or cause the device to be unstable in your body

• cauda equina syndrome, which is a spinal nerve compression that causes bowel or bladder dysfunction

• bone fractures or a diagnosis of severe osteoporosis

• an infection in your blood or anywhere near your lower back where the surgery is planned.

Preparing for Surgery

If you and your surgeon elect to go ahead with the X-STOP IPD procedure, there are several things you can do to help you achieve the best possible outcome for your surgery. You can increase the likelihood of a successful outcome by eating well-balanced nutritional meals as far in advance of your procedure as possible. Poor nutrition can reduce the body’s ability to heal itself.

Spinal surgery is not without risk.

Specific information on the rates of complications for the X-STOP IPD system and spinal surgery should be discussed with your doctor.

Complications that may be associated with XSTOP IPD surgery include, but are not limited to, the following: implant dislodgement (movement out of place), implant not positioned correctly, fracture of the spinous process, foreign body reaction (ex. Allergic reaction), additional surgery-which could include removal of the X-STOP implant

Complications related to any type of surgery may include, but are not limited to, the following: reactions to anesthesia, heart attack, infection, which could require medication or an operation, blood vessel damage/bleeding, bruising (hematoma), pneumonia, blood clots, wound closure problems, spinal cord or nerve damage, pain or discomfort, paralysis, stroke, death

Please consult your doctor about the complication rates related to surgery.

You may feel immediate relief from pain following this procedure. You may be able to walk the same day and you may be discharged from the hospital within 24 hours. Although X-STOP IPD surgery can typically be performed on an outpatient basis, your physician may recommend a short hospital stay.

Following your discharge, physical therapy may be recommended. Your doctor may ask you to return for an examination approximately six weeks later. While your doctor may recommend some limitation in your physical activities in the weeks following your operation, you should be able to travel and engage in light activity as soon as you feel able to. 

Physical activity limitations may include:

• no bending backward

• no heavy lifting

• no stair climbing

• no sports such as swimming, golf, tennis, racquetball, running or jogging.

Post-operative medication is generally not required. Walking is usually acceptable as long as it is comfortable and does not exceed one hour in duration. Normal activity can usually be resumed with the doctor’s recommendation within two to six weeks after the procedure.

It is important for you to realize that you have undergone a surgical operation and that you should not participate in strenuous activities until your doctor has indicated you may do so. You must follow your doctor’s directions carefully in order to fully recover from your surgery.

If you are planning to have other diagnostic procedures or treatments, not related to your

X-STOP IPD surgery, please tell your doctor that you had X-STOP IPD surgery.   

Caution: It is important to follow your doctor’s instructions carefully in order to fully recover from surgery. Failure to follow post-operative care recommendations may result in recurrence of symptoms and discomfort. A stress fracture of the spinous process may occur if strenuous physical activity is resumed too soon post-operatively.

 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 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. During the study, 6% of patients did not have a satisfactory treatment outcome and decided to have a laminectomy operation (removal of part of the vertebra in the spine), at which time the X-STOP implant was removed. In addition, the implant dislodged (moved out of proper position) in one patient after a fall, and the implant was later removed. A second operation was also required in three other X-STOP procedure patients for the following conditions: drainage of a collection of blood, drainage of fluid around the wound, and removal of damaged tissue with secondary closure of the wound (allowing the wound to close on its own).  Please talk with your physician for more details about the clinical study and its results.

We hope that you take the time to discuss alternative treatments with your doctor and that you learn as much as you can about your own particular medical situation.

We also want to make sure that you understand all of the risks of surgery and the potential complications that can follow. It’s important that you understand exactly what the procedure entails – including the risks, benefits and alternative treatments – before you decide to proceed. Always remember that your final decision to go ahead is up to you.

Warning: 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.

Caution: The X-STOP implant is manufactured from a titanium alloy which is known to produce artifacts if you undergo an MRI exam. If you have an MRI exam, after you have had X-STOP IPD surgery, inform your doctor that you have the XSTOP implant. Failure to inform your doctor may affect the quality of diagnostic information obtained from these scans. The X-STOP implant is MRI safe.