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CTSI News
 

PRESTIGE® LP Cervical Artificial Disc

Randall F. Dryer, M.D., of Central Texas Spine Institute, is a principal investigator for this multi-center clinical trial to assess the safety and effectiveness of the PRESTIGE® LP Cervical Disc.  Our clinic is now enrolling candidates for this two-level cervical artificial disc.

This is a randomized clinical trial.  Each patient enrolled in the study will have a 50/50 chance of receiving the PRESTIGE® LP Cervical Disc.  Those patients not randomized to the PRESTIGE® LP Cervical Disc will have a fusion with an anterior cervical plate, which is the current standard of care for patients with two-level degenerative disc disease.

A prior study, concluded in 2005, evaluated the PRESTIGE®  for use in one level of the cervical spine (neck).  This is the first multi-level artificial disc study in the United States.

To participate in this clinical trial, you must, at a minimum, meet the following criteria:

  • At least 18 years of age

  • Not pregnant at the time of surgery

  • Diagnosed with cervical degenerative disc disease

  • Have not responded to non-operative treatment for a period of 6 weeks

  • Meet the following conditions as documented by CT, MRI or plain x-rays: Radiculopathy and/or myelopathy with the presence of disc herniation and/or osteophytes

  • Requires treatment at only two adjacent levels between C3-C4 to C6-C7

  • Are willing to comply with the study plan

All potential candidates are subject to the above and additional non-listed clinical trial criteria.  If you are interested in being considered a candidate for the PRESTIGE® LP Cervical Disc clinical trial, please contact our study coordinator, Amy, via email at studyinfo@pqrinc.com.

   Double-click to view animation of PRESTIGE®


Caution:  Investigational device, limited by Federal law to investigational use.

 

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