Volunteers needed for hospital study of degenerative disc diseases

2012-01-26 / Health & Wellness


Erik Spayde, M.D. Erik Spayde, M.D. Los Robles Hospital and Medical Center has named medical staff member Erik Spayde, M.D., as the clinical investigator for an upcoming trial of degenerative disc disease.

The Lateral Disc Replacement Clinical Trial is sponsored by NuVasive, the company that developed the minimally disruptive surgical investigational device known as the XL TDR.

The XL TDR is a total disc replacement that is implanted from the patient’s side through a 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, at Los Robles Hospital Spayde has completed 10 of the 200 procedures performed so far nationwide.

Participants for the clinical trial are now being enrolled. Participants must be 18 to 70 years of age and meet at least the following criteria.

•Diagnosis of symptomatic degenerative disc disease at one of the following levels of the lumbar spine: L1-L2, L2-L3, L3-L4 or L4-L5.

•Preoperative disability index above a limit determined by a physician’s assessment and questionnaire.

•Unresponsive to nonsurgical treatment for six months.

Some people who meet the criteria listed above may not be eligible to participate in the study. This includes any person who has at least one of the following criteria.

•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.

•Interest in becoming pregnant within the follow-up period of the study as well as those now pregnant.

A clinical research study staff member can determine if applicants are eligible for the study.

For more information, go to http://clinicaltrials.gov or http:// xlmotion.com.

To qualify for participation in the clinical trial, call (805) 379-2322.

Return to top