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November/December 2006
Volume 2, Issue 6
In this Issue:
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The X-Stop: A New Minimally Invasive Surgical Procedure for Spinal Stenosis
An Original Contribution by Frank J. E. Falco, M.D.
St. Francis Medical Technologies has developed a minimally invasive surgical procedure for the treatment of lumbar spinal stenosis (LSS) that has already been used in Europe. The FDA approved the procedure this past Spring 2006. Spinal stenosis can be either congenital or acquired and is characterized by narrowing of the spinal canal or neural foramen resulting in neural compression. Symptoms of spinal stenosis can present as back pain, radiculopathy, gait abnormalities, neurogenic claudication, and bowel/bladder dysfunction. The spinal canal size varies between flexion and extension. Flexion increases and extension decreases the spinal canal size.
Degenerative disc disease is the most common cause for spinal stenosis and is the most common indication for lumbar spine surgery in the elderly. Decompressive surgery consisting of laminotomy, laminectomy and/or foraminotomy is the only option for symptomatic LSS if patients fail conservative treatment (Sept/Oct 2006 The Pain Journal). Unfortunately there are comorbidities associated with spine surgery including mechanical failure and a success rate of only 65% for good and excellent outcomes.
St. Francis Technologies has developed an innovative minimally invasive surgical device, the X-Stop®, for the treatment of spinal stenosis. The X-Stop is indicated for spinal stenosis when symptoms increase with extension and decrease with flexion. The X-Stop is a titanium spacer inserted under local anesthesia anterior to interspinous ligament over the lamina between the spinous processes at symptomatic segmental levels.
The device distracts the disc space and maintains it in a slightly flexed position that reduces extension at symptomatic level(s), while maintaining the dynamic structure of the spine.
 
The X-Stop has demonstrated a 59% one year success rate (comparable to traditional spine surgery), early mobility, reduced morbidity, and decreased recovery time compared to more invasive surgery. The procedure is non-destructive and completely reversible if more extensive surgery is required at a later time. The X-Stop is contraindicated in patients with severe osteoporosis.
Osteoplasty for the Treatment of Pelvic Metastases
An Original Contribution by Frank J. E. Falco, M.D.
Primary tumors known to metastasize to the pelvis include breast, lung, kidney, prostate, and colon. Pelvic lytic lesions are often associated with severe pain and functional disability (standing, walking). Traditional treatment options are limited to radiation therapy, surgery and cordotomy.
Surgery is the treatment of choice when there are no contraindications, such as location of lytic lesions. Other contraindications include existing medical disorders, prior surgical treatment to the same lytic area, and the treatment of sacral metastases. The benefits of surgery must also be weighed against any adverse consequences of surgery and life expectancy.
Radiation therapy typically provides partial or total pain relief after completion of the treatment. Unfortunately, it can take up to 24 months after radiation treatment for bone remodeling. The remodeling often results in minimal bone strengthening that precludes standing or walking in those with extensive lytic lesions or no bone restoration in those with a short life expectancy. In addition, osteoporosis can precede bone remodeling leading to an increased risk for a pathologic fracture.
Cervical spine cordotomy is performed as either an open surgical or percutaneous radiofrequency procedure to provide pain relief from pelvic metastases. This is accomplished by destroying the sacral fibers of the spinothalamic tract at the C1-C2 cord area. There is a significant risk of morbidity and rare mortality with these procedures. They typically only provide temporary pain relief (approximately one year), are indicated for unilateral pain and do not have any impact on bone strength.
Osteoplasty is a percutaneous procedure for the treatment of painful lytic bone metastases. Methylmethacrylate, bone cement, is injected into the lytic lesions through a large bore size needle under fluoroscopy or CT guidance. Osteoplasty is a safe and effective palliative technique for the treatment of pelvic metastases with a very low complication rate and can be repeated if there is a reoccurence of metastases. Osteoplasty allows for immediate pain relief as well as instant restoration of function (standing, walking) secondary to the pain relief and bone strengthening from the cement injection into the lytic lesions.
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