RMSAS is currently conducting a clinical trial utilizing Paradigm Spines’ Coflex™ interspinous implant for patients with lumbar spine stenosis. The device will be compared to a posterior fusion in one or two lumbar levels.  The doctors at RMSAS were the first in the United States to perform this procedure.

Fill out the online application to be considered for this study.

Candidates must generally meet the following criteria:

  1. Radiographic confirmation of at least moderate lumbar stenosis.
  2. Leg/buttocks or groin pain that can be relieved by flexion such as sitting ina chair
  3. Have undergone at least 6 months of prior conservative care, including one epidural injection, without adequate or sustained symptom relief.
  4. Age between 40 and 80 years.
  5. Appropriate candidate for treatment using posterior approach.
  6. Psychosocially, mentally and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms and other study procedures
  7. Cannot have more than two vertebral levels requiring surgical decompression
  8. Cannot have prior fusion or decompressive laminectomy, laminotomy or discectomy at any lumbar level.
  9. Cannot have degenerative lumbar scoliosis
  10. Cannot have Osteopenia.
  11. Cannot be morbidly obese.
  12. Cannot chronically be taking medications or any known drug to potentially interfere with bones/soft tissue healing, not including medrol dos pack.
  13. Cannot have uncontrollable diabetes
  14. Cannot have rheumatoid arthritis or other autoimmune diseases.
  15. No known or documented history of communicable diseases.
  16. No active malignancy.

Other inclusions/exclusions apply.  Please consult RMSAS for full criteria.

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