Lumbar Spinal Stenosis and Interspinous Spacers/MILD

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Spinal stenosis is the story of leg and or back pain and tiredness with walking.  Why? in the walking position, the canal closes in on the nerves coming from and going to the legs and buttocks, strangling them.  Sitting opens the canal allowing the blood to flow back to the nerves.  The interspinous spacer simply holds the spine open, allowing those nerves to perfuse with blood.   Why didn't we think of this earlier?  Why didn't I?  A simple, 20 minute procedure done through a centimeter incision.  So easy. So safe, and what's the competitor?  Lumbar Laminectomy: The prevalence of incidental durotomy during the primary lumbar spine surgery ranges from 6.8% to 15.6% in open surgical series, and from 5.8% to 12.5% in minimally invasive surgical series.The rate of blood transfusions in surgical patients was reported to be 9.9% in the Maine Lumbar Spine study and 14.2% Finally, complications with open surgery  ranges from 13.8% to 27.2%.

Vertiflex?: none of that and dramatic relief.

Minuteman L-TAT Lumbar Transverse Interspinous Fusion.  Sounds a bid scary at first. But this is in actuality an amazing achievement in spine surgery.  Sometimes we need fusion.  It's what the body is working towards on its own, that why those spurs form around the discs and joints in the spine.  Given enough time they will knit together, and all of a sudden you can drive right down the fairway again, without a stitch of pain. But that might take a decade.  The promise of the minuteman is to achieve that stabilization, a "soft fusion" so to speak in a few minutes.  

The Aurora Zip procedure involves the use of a specialized device to stabilize the spine without the need for traditional spinal fusion. During the procedure, a surgeon makes a small incision in the back to access the affected area of the spine. The Aurora Zip device is then inserted to decompress the spinal canal and relieve pressure on the nerves. The device works by holding the vertebrae in place, allowing for natural healing and mobility preservation.

The Aurora Zip procedure offers several benefits over traditional surgical methods, including:

• Minimally Invasive: The procedure requires only a small incision, reducing the risk of complications and promoting faster recovery.
• Preservation of Mobility: Unlike spinal fusion, the Aurora Zip allows for the preservation of spinal mobility, enabling patients to maintain a more active lifestyle post-surgery.
• Reduced Recovery Time: Patients typically experience a shorter recovery period compared to traditional surgery, with many returning to their normal activities within a few weeks.
• Effective Symptom Relief: The procedure has been shown to effectively relieve the symptoms of LSS, improving patients' quality of life.

The MILD procedure is a percutaneous image-guided lumbar decompression technique designed to treat symptomatic LSS that has not responded to conservative therapy. It is a posterior decompression of the lumbar spine performed under indirect image guidance, without direct visualization of the surgical area. This minimally invasive procedure involves the use of specially designed instruments to remove a portion of the lamina and debulk the ligamentum flavum, relieving pressure on the compressed nerves. The procedure is performed under x-ray guidance, with the assistance of contrast media to identify and monitor the compressed area via epidurogram1.

The Centers for Medicare & Medicaid Services (CMS) has recognized the potential benefits of the MILD procedure for treating LSS. On January 9, 2014, CMS issued a Medicare National Coverage Determination (NCD) allowing coverage of the MILD procedure for LSS under Coverage with Evidence Development (CED) with certain conditions. This coverage was expanded on December 7, 2016, to include the procedure under CED in a prospective longitudinal study using an FDA-approved/cleared device that successfully completed a CMS-approved randomized controlled trial (RCT) with specific conditions12.

A comprehensive study comparing outcomes between Medicare beneficiaries receiving the MILD procedure and those receiving interspinous spacers for the treatment of LSS with neurogenic claudication (NC) found that the rate of harms for those treated with the MILD procedure was significantly lower than that of patients implanted with a spacer (5.6% vs. 12.1%, respectively) during a 2-year follow-up. Additionally, the rate of subsequent interventions was not significantly different between the two groups, demonstrating the noninferiority of the MILD procedure compared to spacers4.

For Medicare patients suffering from Lumbar Spinal Stenosis, the MILD procedure represents a promising treatment option that bridges the gap between conservative therapies and more invasive surgical interventions. Its minimally invasive nature, coupled with the support of Medicare coverage under specific conditions, makes it an attractive option for those seeking relief from the debilitating symptoms of LSS. As always, patients should consult with their healthcare provider to determine the most appropriate treatment plan for their specific condition.

Lumbar spinal stenosis (LSS) is a condition that can cause significant discomfort and disability, particularly in the aging population. It is characterized by the narrowing of the spinal canal, which can lead to nerve compression and a range of symptoms including pain, numbness, and weakness in the lower back and legs. Traditional treatments have ranged from conservative therapies to more invasive surgical procedures. However, advancements in medical technology have led to the development of less invasive options, such as the ION facet fusion system, which offers a promising alternative for patients suffering from LSS.

The ION facet fusion system is a minimally invasive surgical technique designed to stabilize the facet joints in the spine. It utilizes micro implants that are significantly smaller than traditional pedicle screws, measuring 30mm-40mm smaller, which can be beneficial in reducing the invasiveness of the procedure1. The system employs a hydrophilic surface created by Nanotex® technology, which takes advantage of ionic bonds to attract and hold bone marrow aspirate (BMA) and other fluids containing key growth factors necessary for osteointegration1. This feature is critical for the fusion process, as it promotes the growth of new bone tissue that can stabilize the spine.The ION facet screw is intended for use from C2 to S1 for bilateral stabilization of the facet joints. The procedure is typically performed in an outpatient surgery center, which can be more convenient for patients and may lead to quicker recovery times1. The system includes a range of orthopedic instruments to assist in the implantation of the titanium facet screw, and all components are provided nonsterile, requiring sterilization before use1.

One of the key advantages of the ION facet fusion system is its less invasive nature compared to traditional spine surgery. The smaller size of the implants and the outpatient setting of the procedure can result in less tissue damage, reduced blood loss, and a quicker recovery for patients1. Additionally, an ovine spine study demonstrated mature bone formation to the Nanotex® surface at three months, with no delamination, indicating a successful integration of the implant1.

The ION facet fusion system is one of several options available for the treatment of LSS. Another minimally invasive option is the Vertiflex Superion implant, which acts as a spacer to relieve pressure on the nerves2. This implant has been shown to be effective in reducing pain and opioid use after five years2. However, the ION system offers a different approach by focusing on the stabilization of the facet joints rather than just decompression.

The World Federation of Neurosurgical Societies Spine Committee has provided recommendations on fusion surgery for LSS, highlighting the complexity and controversy surrounding the role of fusion in treatment3. While the evidence from randomized controlled trials (RCTs) is not unanimous, the committee has formulated indications for when fusion might be necessary in degenerative lumbar stenosis3. Similarly, a retrospective analysis of less invasive decompressive laminectomy and one-level lumbar fusion in the setting of interspinous fixation showed promising results, suggesting that this technique may be beneficial for certain patients4.

For patients with lumbar spinal stenosis, the ION facet fusion system represents a modern, less invasive surgical option that can provide stabilization of the spine with the potential for a quicker and more comfortable recovery. It is important for patients to consult with their healthcare providers to determine the most appropriate treatment for their specific condition. As with any medical procedure, the risks and benefits should be carefully weighed, and the decision should be made in the context of the patient's overall health and treatment goals.