X-STOP is a minimally invasive surgical device designed to alleviate the painful symptoms of lumbar spinal stenosis. The X-STOP device is also called an Interspinous Process Decompression System. X-STOP is an implant made of titanium alloy and is designed to be implanted between the spinous processes in the back of the spine. It consists of two parts: - a spacer assembly and a wing assembly.
Lumbar spinal stenosis is a condition of narrowing in the spinal canal at the lumbar vertebrae which causes compression of the spinal nerves, resulting in low back pain. The condition causes pain, numbness or a tingling sensation over the lower back, buttocks and legs along with weakness in the legs. Forward bending or sitting can reduce the pain whereas backward bending aggravates the pain. The X-stop device prevents backward extension of the spine and maintains an open space for the nerves to pass through by spreading the vertebrae apart.
The benefits of the X-STOP procedure compared to traditional spinal surgery for lumbar spinal stenosis, includes the following:
- The X-stop procedure can be performed under local anesthesia
- It can be performed on an outpatient basis
- It is a reversible procedure that doesn’t restrict any future treatment options.
- There is no removal of bone or soft tissue, which allows for a quicker recovery
X-STOP implantation procedure
The procedure can be performed in the operating room or a special procedure room at the hospital. Usually, the procedure is carried out under local or general anesthesia along with X-ray guidance. The procedure lasts about 45 to 90 minutes. The X-STOP implantation is done through a small incision in the skin over your lower back. The device is placed between the spinous processes of the vertebrae in your lower back, where the lumbar stenosis is present. Spinous processes are the thin bony projections that arise from the back of the spinal bones and serve as attachments for spinal muscles and ligaments. The X-stop device limits the extension of the spine in the affected area, but allows forward bending and rotation of the lower back to a certain extent.
The X-STOP implant is indicated for the treatment of the following type of patients:
- Patients with a confirmed diagnosis of lumbar spinal stenosis
- Patients suffering from leg pain and/or buttock or groin pain, a condition known as neurogenic intermittent claudication.
- Patients aged 50 or older, with moderately impaired physical function
- Those who have undergone at least six months of non-surgical treatment such as pain medication, physical therapy, and epidural injections without satisfactory pain relief.
- and Patients with significant stenosis present at one or two lumbar levels
The X STOP should not be used in patients with:
- An allergy to titanium or titanium alloy
- Spinal diseases such as ankylosing spondylitis or spondylolisthesis may interfere with the implantation of the device and may cause the device to be unstable in the body.
- Those with severe osteoporosis
- Patients with active systemic or localized infection of the lower back
- or those with Cauda equina syndrome, a spinal nerve compression that causes bowel or bladder dysfunction.
Generally, the implantation of the X-STOP device is considered safe and beneficial. As with other surgical procedures, there are certain risks involved and may include the following:
- The need for additional surgery such as a laminectomy which could include removal of the implant
- Implant dislodgement
- Failure of the device to relieve the symptoms
Post-operative care of the X-STOP implantation includes immediate ambulation to hasten the healing and recovery process and to reduce the chances of post-operative complications. Sometimes pain medications are required to control post-operative pain or soreness. Physical therapy usually focuses on mild stretching and strengthening exercises, followed by low-impact aerobic exercises.
A follow-up visit will be scheduled about six weeks after the surgery. Patients will be prohibited from performing certain activities while healing such as forward bending, lifting heavy objects, stair climbing or vigorous physical activity during which the lower back could be repeatedly twisted, jarred or stretched.
Most people can resume all of their normal activities within two to six weeks after the procedure.
X-STOP is a small titanium implant used to treat the symptoms of lumbar spinal stenosis and improve a patient’s ability to function with activities of daily living.