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Los Robles Physician Heads Trials for Disc Disease

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January 03, 2012

Los Robles Hospital & Medical Center is on the cutting edge of spine research through the naming of medical staff member, Erik Spayde, M.D. as the only clinical investigator for this clinical trial of degenerative disc disease in Southern California.

Dr. Spayde, who is fellowship trained in motion preservation disk replacement, is one of only 17 sites chosen throughout the United States for the Lateral Disc Replacement Clinical Trial sponsored by NuVasive, the company who developed the minimally disruptive surgical investigational device known as the XL TDR.

Unlike other total disc replacement devices, the XL TDR is a total disc replacement that is implanted from the patient’s side through a small 2 inch incision. Traditionally, the surgery is done through the stomach which involves the potential for increased infection, more complications and a longer hospital stay.

The clinical trial seeks to demonstrate the safety and effectiveness of this device, compared to fusion procedures. Instead of achieving pain relief through fusion, which is the immobilization of a spinal disc, the device seeks to provide long-term stabilization of the spine and maintain one of the secondary functions of the disc, which provides motion in the spine.

To date, Dr. Spayde has completed at Los Robles Hospital ten of the 200 procedures performed so far nationwide.

Participants for the clinical trial are now being enrolled. Criteria for participation in the clinical trial include, but are not limited to:

Inclusion Criteria

  • Participants must be 18-70 years of age and meet at least the following criteria:
  • Diagnosis of symptomatic degenerative disc disease (DDD) at one (and only one) of the following levels of the lumbar spine:
  • L1-L2
  • L2-L3
  • L3-L4
  • L4-L5
  • Preoperative Disability Index above a limit determined by a physician’s assessment and questionnaire.
  • Unresponsive to non-surgical treatment for 6 months.

Exclusion Criteria

Some people who meet the criteria listed above may not be eligible to participate in this clinical research study. This includes any person who has at least one of the following criteria, among others:

  • Symptomatic multilevel lumbar DDD.
  • Previous or other lumbar spinal surgery at any level, except prior discectomy, laminotomy, or nucleolysis at the same level.
  • Another implanted lumbar device.
  • Severe osteopenia or osteoporosis.
  • Morbid obesity (body mass index >40).
  • Interest in becoming pregnant within the follow-up period of the study. (You will also be excluded if you are currently pregnant.)

Other Criteria

The criteria listed above are not the only eligibility requirements for this study. Only a clinical research study staff member can determine if you are eligible for this clinical research study.

For further information, please refer to clinicaltrials.gov or xlmotion.com. To see if you qualify for participation in the clinical trial, please call the clinical trial site at 805-379-2322.

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