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Slide 1 - Home - Huron Valley-Sinai Hospital

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  • Your spine consists of a column of 24 bones called vertebrae that extend from your skull down to your hips (Fig. 1). Between the vertebrae are discs of soft tissue. The spinous process are the bony structures that stick out of the vertebrae. Interspinous space is the area between the spinous process
  • The vertebrae are the building blocks, providing support for your head and body while the discs act as cushions, or “shock absorbers.” In addition to providing support, the spine encloses and protects a column of nerve tissues called the spinal cord. The spinal cord is surrounded by a bony channel called the spinal canal. In the lumbar spine, nerve roots pass out of the spinal canal through the intervertebral foramen, where they extend down into your back and legs. In the healthy spine, there is space between the spinal cord and the borders of the spinal canal so that the nerves are free and are not pinched. However, as we age the ligaments and bone that surround the spinal canal can thicken. This thickening results in narrowing of the spinal canal, which is called “spinal stenosis.” The spinal cord and nerve fibers that exit the spinal canal (nerve roots) become crowded and pinched due to this narrowing, resulting in pain and numbness in the back and legs.
  • In extension, the canal area increased by 18% - this is seen in both the side-by-side comparison of the yellow area of the intact specimen, and the white area of the X STOP implanted specimen. We can superimpose these two areas which helps demonstrate the difference. We also measured the canal diameter, which increased by 9%. Again, the comparison can be further emphasized by this direct, side-by-side comparison. Finally, we showed that the subarticular diameter, which represents the lateral recess, increased by 50% following X STOP implantation. So we can see here these critical dimensions are significantly increased following X STOP implantation.
  • Extension and Flexion are two “medical” terms that are challenging to remember but very important to understand if you suffer from lumbar spinal stenosis. For the purposes of this presentation, the easiest way to remember what each term means is to think of it this way: Extension happens when you stand and flexion happens when you sit or lean forward. This is important, because as you can see from the illustrations, the nerve area of the spine becomes more compact in extension and more open during flexion. Flexion occurs when you sit or bend forward. As you can see in the slide, bending forward opens up nerve area and may reduce symptoms.
  • We used the same method to analyze para-sagittal images to measure changes in the foraminal area. The foraminal area increased by 25% following X STOP implantation and, again, this can be seen in both the side-by-side comparison as well as by superimposing the two areas. The foramen width increased by 41% following implantation. Again, these results show that critical dimensions are significantly increased following X STOP implantation.
  • When the patient stands straight up (extension), they extend their spines with the result being increased symptoms of stenosis. The best description that I’ve ever heard of these symptoms came from a patient who said to me “sometimes when I walk it feels like an electric storm shooting down my leg.” As the lumbar spine is in extension while standing, symptoms may be reduced by leaning forward and may be eliminated by sitting, which places the lumbar spine slightly into flexion.
  • Traditional LSS treatment options covered the extremes - ranging from non-operative care for mild symptoms to the invasive, open, tissue removing surgery such as laminectomy for more severe symptoms.
  • X-STOP fills a need for a more moderate LSS treatment option X-STOP fills a gap in the continuum of care for patients who suffer from the symptoms of lumbar spinal stenosis that, until now, required patients to choose between conservative therapies, such as analgesics and injections, and traditional surgical decompression procedures, such as laminectomy
  • In the Pre-Op illustration we can see that the spinous processes (bony structures that stick out of the vertebra) are “kissing” and the nerve roots are compressed. The X-STOP implant is placed between the spinous processes separating then and relieving the pinched nerves of the symptomatic level during a minimally invasive surgical procedure
  • The X-STOP device relieves the symptoms of lumbar spinal stenosis by limiting extension without any significant restriction of flexion or lateral rotation. Additionally, the X-STOP Spacer addresses many of the traditional concerns about destabilization of the spine associated with invasive decompressive procedures such as laminectomy. The X-STOP procedure does not typically require removal of bony structures or the supraspinous ligament. Preserving the supraspinous ligament has the added benefit of working along with the device’s wings to prevent lateral and posterior migration.
  • The X-STOP Spacer 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 Spacer. These patients were compared to 91 patients who did not have surgery, but were treated by their doctors with non-operative care (for example, with medications, physical therapy, etc.). In this study, the X-STOP Spacer was clinically proven to treat the major symptoms of lumbar spinal stenosis, by reducing pain and improving physical function, resulting in increased patient satisfaction, leading to overall treatment success.
  • The next four slides contain the exact approved patient selection language as it appears in the X-STOP device IFU. Here we present the indications for use.
  • Here we see the contraindications for the X-STOP implant.
  • Important warnings and precautions to understand before the device is implanted.
  • Finally, potential adverse events.

Slide 1 - Home - Huron Valley-Sinai Hospital Slide 1 - Home - Huron Valley-Sinai Hospital Presentation Transcript

  • Lumbar Spinal Stenosis: Symptoms and Treatment Miles L Singer DO FACOS, FAOAO Michigan Spine Institute 5220 Highland Road, Ste 210 Waterford, MI 48327 248-383-1030
    • Introduction
    • Anatomy of the Spine – Helpful Terms
    • Clinical Presentation
    • Symptoms of Lumbar Spinal Stenosis
    • Treatment Options
      • Non-Operative & Surgical Treatment
      • A New Alternative
    Agenda
    • 8 - 11% Incidence of LSS in the U.S. 1
    • LSS is the most common reason for spine surgery in older people 2
    • More than 125,000 laminectomy procedures were performed for LSS in 2003 3
    • Financial impact and lost work hours reaches billions of dollars each year in the U.S. 4
    Lumbar Spinal Stenosis (LSS)
    • Murphy et al, BMC Musculoskeletal disorders, 2006, Jenis et al, Spine 2000.
    • Murphy et al, BMC Musculoskeletal disorders, Sepals, European Spine Journal, 2003
    • The Ortho FactBook™; U.S. 5th Edition; Solucient, LLC and Verispan, LLC
    • Knowledge Enterprises, Inc.
  • Anatomy of the Spine
  • Anatomy of the Spine Understanding your spine: Helpful Terms Spinous Process Interspinous space Vertebra Disc Lumbar Spine (L1-L5)
    • Vertebrae provide support for your head and body
    • Discs act as “shock absorbers”
    • Vertebra protects spinal cord
    • Nerves have space and are not pinched
    • As we age, ligaments and bone can thicken
    • Narrowing is called “stenosis”
    • Narrowing impinges on nerves in spinal canal and nerve roots exiting to the legs
    • Result - pain & numbness in back and legs
    Lumbar Vertebra Nerve Root Spinal Canal Bone (Facet Joint) Healthy Intervertebral Disc Stenotic Thickened Ligament Flavum Pinched Nerve Root Narrowed Spinal Canal
    • Axial MRI slices of extended cadaver specimens showed
    CANAL DIMENSIONS
    • Canal area:  18%
    • Canal diameter:  10%
    • Subarticular diameter:  50%
    • No significant change at adjacent levels
    Pre-Implant Post-Implant Richards – Spine 2005 Miles L Singer, DO, FACOS,FAOAO
  • Anatomy of the Spine
    • Understanding your spine: Helpful Terms
    Extension – occurs when standing Flexion – Occurs when sitting or bending forward Miles L Singer, DO, FACOS,FAOAO
  • FORAMEN DIMENSIONS Para-sagittal MRI slices of extended cadaver specimens showed
    • Foramen area:  25%
    • Foramen width:  41%
    • No significant changes at adjacent levels
    Pre-Implant Post-Implant Richards – Spine 2005 Miles L Singer, DO, FACOS,FAOAO
  • Symptoms of Lumbar Spinal Stenosis
    • Sitting or bending forward relieves symptoms
    • Standing provokes symptoms
    • Pain/weakness in the legs
    • Patients lean forward while walking to relieve symptoms
    • Classic Presentation:
    • Dull or aching back pain spreading to your legs
    • Numbness and “pins and needles” in your legs, calves or buttocks
    • Weakness, or a loss of balance
    • A decreased endurance for physical activities
    Symptoms of Lumbar Spinal Stenosis X-STOP Patient Brochure – FDA Patient Labeling
    • Lack of activity may lead to:
    • Obesity
    • General physical deterioration
    • Depression/other psychological problems
    • Worsening of co-morbidities
    Burden of Lumbar Spinal Stenosis Treatment of Degenerative Lumbar Spinal Stenosis, Agency for Health and Quality 2004
  • Treatment Options
  • Lumbar Spinal Stenosis Treatment Options
    • Surgical Care
    • Laminectomy
    • Laminectomy with Fusion
    • Micro Endoscopic Decompressive Laminectomy
    • Laminotomy- facetectomy
    • Non Operative Care
    • Epidural injections
    • Physical therapy
    • NSAIDs & other drugs
    • Lifestyle modification
    • Exercise & weight reduction
    Spinal Stenosis Symptoms: Continuum of Care Mild Severe Moderate Atlas - Clin Orth Rel Res 2006 .
    • Non-operative care
    • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
      • Reduce swelling and pain, and analgesics to relieve pain
    • Epidural Steroid Injection
      • Reduce swelling and treat acute pain that radiates to hips or down the legs
      • May be temporary
      • Typically limited to 3 injections every six months
    • Physical Therapy, Exercise & Weight Reduction
      • To help stabilize the spine
      • Build endurance
      • Self-limiting activities of daily living
    Lumbar Spinal Stenosis Treatment Options Standard of Care: Mild to Moderate Symptoms Atlas - Clin Orth Rel Res 2006 .
  • Lumbar Spinal Stenosis Treatment Options Standard of Care: More Severe Symptoms
    • Laminectomy
    • Referred to as “unroofing” the spine
    • Removal of parts of the vertebra, including:
      • Lamina (bone)
      • Attached ligaments
      • Facets (bone)
    • Goal: relieve pressure on spinal cord and nerves by increasing area around spinal canal and neural foramen
    • Most common surgery for stenosis, may require a fusion 1,2
    • General anesthesia 1,2
    • In-patient procedure 1,2
    • OR time: 1.5 – 4.5 hours 1,2
    • Average length of hospital stay: 4 days 1,2
    • Turner – Spine 1992
    • Atlas - Clin Orth Rel Res 2006 .
    • Surgical Care
    • Laminectomy
    • Laminectomy with Fusion
    • Micro Endoscopic Decompressive Laminectomy
    • Laminotomy- facetectomy
    Lumbar Spinal Stenosis Treatment Options
    • Non Operative Care
    • Epidural injections
    • Physical therapy
    • NSAIDs & other drugs
    • Lifestyle modification
    X-STOP ® Spacer Spinal Stenosis Symptoms: Continuum of Care Mild Severe Moderate Atlas - Clin Orth Rel Res 2006 .
  • X-STOP ® Spacer for Lumbar Spinal Stenosis
  • The X-STOP ® Spacer
    • X-STOP Spacer is implanted, separating the spinous processes and relieving pinched nerves
    • Designed to remain safely and permanently in place
    • The first Interspinous Spacer approved by FDA to treat the symptoms of LSS
    Pre-Op Post-Op “ Kissing” Spinous Processes
  • The X-STOP ® Spacer
    • Minimally invasive procedure
    • Rapidly alleviates pain
    • Typically doesn’t require the removal of bone or tissue
    • Can be done under local anesthesia
    • Low rate of complications 1,2
    • Not attached to bone or ligaments
    • Zucherman – Spine 2005
    • X-STOP® IPD® System Instructions For Use (IFU)
  • The X-STOP ® Spacer
    • Spacer only limits extension
    • Wings prevent side-to-side and upward migration
    • Preserves your supraspinous ligament, which prevents backward migration
    • Preserves anatomy
    • Treats LSS symptoms, not “anatomy”
    Supraspinous ligament Spinous process Siddiqui – Spine 2006
  • X-STOP ® Superior to Non-operative Care Differences between X-STOP and Control groups statistically significant (p < 0.001) at all follow-up intervals. (all 3 criteria) SOURCE: X-STOP ® IPD ® System Summary of Safety and Effectiveness (SSE); Includes all study sites.
    • Compared to traditional LSS surgery, X-STOP benefits include:
    • Can be done under local anesthesia
    • Can be done as an outpatient procedure
    • No removal of the lamina (vertebral bone) or ligaments that protect and stabilize the spine
    • Potential of a shorter recovery
    The X-STOP Spacer X-STOP Patient Brochure – FDA Patient Labeling
  • Are you a candidate?
    • The X-STOP Spacer is indicated for:
    • People aged 50 or older
    • Pain or weakness in the legs
    • Confirmed diagnosis of lumbar spinal stenosis
    • Moderately impaired physical function
    • Experience symptom relief in flexion (sitting)
    • Completed 6 months of non-operative treatment
    • Operative treatment indicated at one or two lumbar levels (but no more than 2 levels)
    See X-STOP ® IPD ® System Instructions For Use (IFU) for complete product labeling
  • Questions & Answers
  • X-STOP ® IPD ® System Instructions For Use (IFU)
    • Indication for Use
    • The X STOP Interspinous Process Decompression (IPD) System (“X STOP”) is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X STOP is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X STOP may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
  • X-STOP ® IPD ® System Instructions For Use (IFU)
    • Contraindications
    • The X STOP is contraindicated in patients with:
    • an allergy to titanium or titanium alloy;
    • spinal anatomy or disease that would prevent implantation of the device or cause the device to be unstable in situ, such as:
      • significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4);
      • an ankylosed segment at the affected level(s);
      • acute fracture of the spinous process or pars interarticularis
      • significant scoliosis (Cobb angle greater than 25 degrees);
    • cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
    • diagnosis of severe osteoporosis, defined as bone mineral density (from DEXA scan or some comparable study) in the spine or hip that is more than 2.5 SD below the mean of adult normals in the presence of one or more fragility fractures;
    • active systemic infection or infection localized to the site of implantation.
  • X-STOP ® IPD ® System Instructions For Use (IFU)
    • Warnings
    • The X STOP implant must be placed in the concavity between the spinous processes. Posterior positioning of the implant may result in dislodgement. If correct placement of the implant cannot be achieved due to variant anatomy, the surgeon should consider aborting the procedure because incorrect placement may result in device dislodgement, particularly if the patient experiences a traumatic event.
    • Precautions
    • Radiological evidence of stenosis must be correlated with the patient’s symptoms before the diagnosis can be confirmed.
    • If the spinous processes at the affected level are not distracted in flexion, the X STOP may not be indicated.
    • The safety and effectiveness of the X STOP device has not been studied in patients with the following conditions: axial back pain without leg, buttock or groin pain; symptomatic lumbar spinal stenosis at more than 2 levels; prior lumbar spine surgery; significant peripheral neuropathy; acute denervation secondary to radiculopathy; Paget’s disease; vertebral metastases; morbid obesity; pregnancy; a fixed motor deficit; angina; active rheumatoid arthritis; peripheral vascular disease; advanced diabetes or any other systemic disease that may affect the patient’s ability to walk.
    • Surgeons should not implant the X STOP until receiving adequate training regarding surgical technique. Inadequate training may result in poor patient outcomes and/or increased rates of adverse events.
    • A stress fracture of the spinous process may occur if strenuous physical activity is resumed too soon postoperatively.
    • The X STOP is supplied sterile; however, the instruments are supplied non-sterile and must be properly cleaned and sterilized prior to surgery.
  • X-STOP ® IPD ® System Instructions For Use (IFU)
    • Potential Adverse Events
    • The following potential adverse events may occur as a result of interspinous process decompression with the X-STOP system; some of these adverse events were reported in the Pivotal Clinical Trial. X-STOP system related: implant dislodgement/migration; implant not positioned correctly; fracture of the spinous process; additional surgery, which could include removal of the X-STOP implant; foreign body reaction; mechanical failure of the device; failure of the device/procedure to improve symptoms and/or function. Surgery Related: reactions to anesthesia; myocardial infarction; infection; blood vessel damage/bleeding; deep vein thrombosis; hematoma; pneumonia; neurological system compromise; stroke; nerve injury or spinal cord damage; paralysis; thrombus formation; wound dehiscence or delayed healing; pain/discomfort at the operative site; and death.
    • Note: Medication or additional surgery may be necessary to correct some of these potential adverse events.
  • “ Everyone gets lucky once in a while” Even the blind squirrel
    • Thank You!
    • Michigan Spine Institute
    Miles L Singer, DO, FACOS,FAOAO