The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.
Condition or disease
This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System
Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
Will receive a decompression for lumbar stenosis
Symptoms of leg and/or back pain
One pathological level
Between the ages of 20 and 80 at the time of surgery
Non-responsive to non-surgical treatment for at least six months
Planned complete facetectomy
Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
Use in the cervical spine
Active systemic or local infection
Extreme obesity as defined by a Body Mass Index (BMI)over 40. BMI calculated using Appendix A, adapted from the National Heart, Lung, and Blood Institute, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
Severe osteoporosis or osteopenia. The World Health Organization defines osteoporosis as BMD<-2.5t. Professional discretion should be used and if bone quality is in question a DEXA scan is recommended.
Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
Alcohol or drug abuse
Patient unwilling or unable to follow postoperative instructions
Soft tissue deficit not allowing sound closure
Any medical or physical condition that would preclude the potential benefit of spinal surgery
Inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices;
Any medical or mental condition which would exclude the patient at high risk from surgery of the severity
Immobilization of spinal segments as an adjunct to fusion in the treatment of the following:
acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine
degenerative spondylolisthesis with objective evidence of neurologic impairment
failed previous fusion (pseudarthrosis).
Additional relevant MeSH terms: