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The X-Stop procedure is the first non-fusion treatment for patients with lumbar spinal stenosis. The procedure uses a titanium implant designed to keep the spinal canal open, which relieves the compression that causes the pain. This effective surgery is performed at Stamford Hospital by specially trained surgeons, successfully providing relief for patients with moderate lumbar spinal stenosis.
The X-Stop is an implant installed surgically in a minimally invasive procedure that takes about 45 minutes, delivering relief from the intense pain that people with spinal stenosis suffer when standing upright.
It works by enlarging the space between the bones in your back, reducing pressure on the spinal nerves and thus soothing the leg pain, cramping, numbness and tingling that characterize LSS. FDA-approved since 2005, the X-Stop Spacer has undergone many clinical studies. It is a good alternative for people suffering with LSS who have not responded to non-surgical treatment.
After surgical implantation, the X-Stop Spacer remains safely and permanently in place, but requires no screws or hardware. Another advantage is that the X-Stop requires no bone or tissue removal, therefore preserving the natural anatomy of the spine.
By enlarging the space between the bones in your back,
The X-StopPK® device reduces pressure on the spinal nerves, thereby alleviating the symptoms of lumbar spinal stenosis, including : -
Leg pain, cramping
Numbness or tingling in the lower back, buttocks and legs
The X-StopPK® device has undergone clinical studies and is the only device approved by the FDA to treat the symptoms of LSS. The X-StopPK® IPD® procedure offers superior relief of LSS symptoms and overall treatment success when compared with non-surgical treatment. The X-StopPK® device is designed to remain safely and permanently in place without attaching screws or hardware to the bone or ligaments in your back. In addition, the bone and tissue removal typically associated with traditional back surgery is not necessary with this device, thus, the natural anatomy of the spine is preserved.
Indications
Lumbar spinal stenosis is a narrowing of the spinal canal of the low back. Normal wear and tear (degenerative change) affects everyone to some extent during their middle years causing dehydration of the intervertebral discs, reduction of spinal disc height and spinal facet joint arthrosis. It is the most common cause of back-ache but may also, when severe, narrow the spinal canal to pinch the nerve roots. Unlike disc rupture which can cause sciatica, lumbar spinal canal stenosis does not normally cause pain in the legs at rest.
Usually, enough space remains for the nerves to be in a position which the patient finds comfortable most of the time, butleaning backwards (spinal extension) narrows the canal slightly, and leaning forwards (spinal flexion) enlarges it. Characteristically discomfort in the form of nerve pain,tingling, numbness, or additionally weakness, develops when standing or walking any distance (extension), and is only relieved by sitting or leaning forwards (flexion).
Safety
At one year post implantation the active intervention arm of a RCT found that reoperation was required in 6% (5/88) of patients1. A small case series of 10 patients found blood loss to be <100ml in all cases3.
Intraoperative complication rates among 100 patients undergoing interspinous implant in a randomised controlled trial were 1% (1 case each) for the following complications; respiratory distress, ischemic episode, pulmonary oedema, wound dehiscence, wound swelling, haematoma, and incision pain. At two years follow up there was one incident each of implant misplacement, implant migration, spinous fracture, and increased pain at the implant level.
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The X-StopPK® device has undergone clinical studies and is the only device approved by the FDA to treat the symptoms of LSS. The X-StopPK® IPD® procedure offers superior relief of LSS symptoms and overall treatment success when compared with non-surgical treatment. The X-StopPK® device is designed to remain safely and permanently in place without attaching screws or hardware to the bone or ligaments in your back. In addition, the bone and tissue removal typically associated with traditional back surgery is not necessary with this device, thus, the natural anatomy of the spine is preserved.
