It’s important to remember that the goal of all lumbar spinal stenosis (LSS) treatment is to help you regain a satisfactory quality of life.

Once you have been diagnosed with LSS, your doctor may recommend “conservative” treatment for the first several months to relieve your symptoms. These treatments can include pain medications, physical therapy, and steroid injections. If your pain continues or worsens, you and your doctor will discuss other options.

Many people with LSS suffer quietly because they think nothing else can be done to relieve their pain. Or because they fear the invasive nature and prolonged recovery time of major surgery. But today there is a treatment that can provide effective, sustained pain relief with a short, less invasive surgical procedure. It’s called the X-STOP Spacer. This low-risk option may be the treatment you’ve been waiting for.

Many others with LSS stay with nonsurgical treatment because they believe their condition will improve. Several long-term clinical studies have followed patients who managed their LSS symptoms with nonsurgical treatment. These studies report that some patients’ symptoms do improve but a majority remain the same or worsen.8, 12

The following section is designed to help you make an informed and careful decision about your treatment options—and to assess whether you are receiving the best possible treatment.

Nonsurgical care

Pain medications

Physical therapy

Epidural steroid injections

Surgical treatments

Laminectomy

The X-STOP Spacer

Nonsurgical care

The aim of nonsurgical therapy for LSS is to reduce inflammation and swelling in the lumbar region (lower back), relieve pain and other symptoms, and work to stabilize the spine. If you are in the early stages of LSS or if your symptoms remain mild, your doctor may recommend treatment that includes any or all of the following: oral pain medications, physical therapy, and epidural steroid injections.

Considerations

Nonsurgical treatment of LSS may only provide temporary relief or mask the symptoms. Since LSS is considered a progressive disease, periods of pain and disability may become longer or more severe.

The experience of pain is very personal. Your doctor relies on you to report how well or how poorly your current therapy is working to satisfy your needs. If your LSS symptoms are no longer relieved by nonsurgical therapy, you may want to talk to your doctor about other options, including the X-STOP Spacer.

Pain medications

Pain medications provide temporary symptom relief. Pain relievers such as acetaminophen can control pain, but they do not relieve inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) relieve pain and reduce inflammation and swelling. NSAIDs include aspirin, ibuprofen, and naproxen.

NSAIDs vary in potency, duration of action, the ways in which they’re eliminated from the body, and their side effects. Individual responses to different NSAIDs vary widely, too. Someone who does not gain symptom relief from one NSAID may get relief from another.

Risks and other considerations

NSAIDs are associated with a number of side effects. Side effects vary between NSAIDs and can include nausea, diarrhea, constipation, drowsiness, ulcers, bleeding, kidney failure, and liver failure. NSAIDs may also interact with other drugs. Talk to your doctor for more information.

Other prescription pain relievers may have sedative effects or addictive effects.

You and your doctor should work together to see how each medication affects you and your ability to function. Combinations of medications and dosage increases should also be carefully monitored to avoid potentially dangerous side effects.

Over time, your body may require larger doses to achieve the same level of relief. Your condition may also get worse. If your pain and other symptoms intensify, your doctor may increase your dosage of pain medications.

Physical therapy

Physical therapy is prescribed to help you build and maintain your spinal flexibility and stability. A physical therapist will help you develop an individualized program with specific activities for your particular health and history. By working together, you can gradually increase your overall strength, endurance, and flexibility. It’s important to start slowly, stay with the program, and always follow your therapist’s and physician’s directions.

Learn about epidural steroid injections.

Epidural steroid injections

If the first line of therapy fails to relieve your pain—or no longer provides adequate pain relief—your doctor may prescribe an epidural steroid injection. Learn about epidural injections.

The medication is injected into the spinal canal. The injection contains an anti-inflammatory medication plus a medicine to numb your pain. The injected medicine goes to work immediately. However, in most instances, the effects are not permanent and repeat injections, or a regular schedule of injections, are necessary to provide ongoing relief. Additionally, due to potential side effects, the number of injections that can be given over a 6-month period is usually limited.

Risks and other considerations

If short-term side effects occur, they are usually minor and may include: back pain and tenderness for 2 to 4 days at the location of the injection, nausea, vomiting, dizziness, and headache. More serious side effects are very rare but can include bleeding, infection, nerve injury, and meningitis.

Surgical treatments

Surgery is normally recommended when nonsurgical treatments have failed to relieve your symptoms. Surgical decompression is the general term for the most common form of surgical procedure performed in patients with LSS. During these procedures, bone or soft tissue is removed from the spine to relieve the pressure on the nerves that cause LSS symptoms.
Learn how the X-STOP Spacer treats LSS symptoms.

See how a laminectomy is performed.

Laminectomy

The most commonly performed decompressive surgery for patients with LSS is a laminectomy. The aim of a laminectomy is to take the pressure off the pinched nerve. To do this, parts of the vertebrae, including the lamina (bone that forms the back wall of the spinal canal) and attached ligaments (tough elastic bands of tissue connecting to the vertebrae) that cause compression of the spinal cord and nerve roots, are permanently removed to create more space for the nerve.

Removing the lamina and ligament tissue increases the space around the pinched nerve and allows access to bone spurs or ruptured discs that may also be causing the problem. Bone spurs and disc material may also be removed during a laminectomy using special cutting instruments or a drill.

A laminectomy requires general anesthesia. Generally, an incision 3 to 5 inches long is made in the back. Muscle positioned over the lamina is also cut or separated to allow access to the area.

When the nerve area has been decompressed, the surgeon uses dissolvable stitches to close the layers of muscle, ligaments, and tissue. Staples or dissolvable stitches may be used to close the skin incision.

Sometimes, only part of the lamina must be removed to relieve the pressure on the nerves. This procedure is called a laminotomy.

When a laminectomy is performed less invasively, it is called a microlaminectomy or a microendoscopic laminectomy.

Recovery

Following a laminectomy, the typical recovery time in the hospital is up to 3.5 days.14 It usually takes up to 6 months before you can resume normal physical activities.14 Of course, recovery time depends on factors such as your age and your physical condition at the time of surgery.

Risks and other considerations

A laminectomy does not always provide relief from painful LSS symptoms. One study showed that up to 40% of people who had this surgery graded their condition as unchanged or worse.16

A laminectomy is a major surgery with a number of potential risks, including:

• General anesthesia complications, such as a heart attack, blood clots, stroke, pneumonia, or pulmonary embolism.
• Nerve damage or bowel and bladder incontinence.
• A cerebrospinal fluid leak may occur if the protective membrane around the spinal column is broken. If this happens, surgery can continue. Generally, a patient must lie down for about 24 hours to allow the leak to seal.
• Infection can occur and may require an additional surgery along with intravenous antibiotics.
• Bleeding is an uncommon complication.
• Paralysis is extremely unusual.

Postoperative complications

• Spinal instability may occur in approximately 6% of cases.14
• Weakening or cutting the bony structure can lead to an isthmic spondylolisthesis after surgery.
• Spinal fusion at a later date may become necessary.

Foraminotomy

This decompressive surgery focuses on enlarging the passageway where the nerve exits the spinal canal. The passageway is called the neuroforamen space. The surgery works to remove any bone and tissue that block the passageway and pinch the nerve. As with other invasive spinal surgeries, it requires cutting through or separating back muscle and likely will include removal of ligament tissue. A foraminotomy can be performed alone or at the same time as a laminectomy or a laminotomy.

Spinal fusion

Spinal fusion permanently connects two or more vertebrae using pieces of bone (your own or bone provided by a donor or bone bank) and optional hardware such as screws, rods, and cages.

Sometimes spinal fusion procedures are performed in conjunction with decompressive surgeries on patients with LSS. Spinal surgeons choose to perform a fusion along with a decompression for one of two reasons:

1. During a decompressive surgery, the surgeon may remove so much bone that the stability of the spine is affected. When this happens, a fusion is used to reinforce the stability of the spine.
2. A surgeon may decide that a patient’s symptoms will not be alleviated by a decompressive surgery alone. In this case, the surgeon may decide that a spinal fusion will increase the likelihood that the patient will experience sufficient relief.

Risks and other considerations

As with any surgery, complications due to infection, bleeding, and problems related to the anesthetic may occur. Other risks include urinary difficulties and reduced, or lack of, intestinal function.

The X-STOP Spacer

Filling an important gap in the continuum of LSS treatment

Until the X-STOP Spacer became available, people with LSS who were no longer satisfied with their pain relief from nonsurgical treatments, such as oral medications and epidural steroid injections, had to have major surgery, like a laminectomy. The X-STOP Spacer may provide sustained relief of painful LSS symptoms with a less invasive surgical procedure.

It’s an ingenious and simple implant that works by opening up the space around the pinched nerve. By “unpinching” the nerve, the X-STOP Spacer may relieve painful symptoms of LSS—even when you stand or walk.

What is the X-STOP Spacer?

Watch and learn more about how the X-STOP Spacer can relieve pain.
Hear what X-STOP Spacer patients have to say about their experience.
Read more about how the X-STOP Spacer works.
For risks and possible complications, please review the important safety information.

Learn how the X-STOP Spacer compares with other treatments

Learn how the X-STOP Spacer compares with nonsurgical treatment.
Learn how the X-STOP Spacer compares with a laminectomy.

Risks and Considerations

The X-STOP Spacer is indicated for patients aged 50 or older suffering from lumbar spinal stenosis (LSS). A diagnosis of LSS should be confirmed by a doctor with X-ray, MRI, or CT scans. The X-STOP Spacer 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 Spacer should have been on a regime of nonsurgical treatment for their symptoms for at least 6 months. The X-STOP Spacer may be implanted at one or two lumbar levels of the lumbar spine.

The X-STOP Spacer should not be used if you have: An allergy to titanium or titanium alloy and PEEK (the X-STOP Implant is made from these materials); 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.

Please review this important safety information.