Posterior Lateral Fusion (PLF) With Dynesys

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00791180
First received: November 13, 2008
Last updated: September 28, 2011
Last verified: September 2011

November 13, 2008
September 28, 2011
March 2006
March 2011   (final data collection date for primary outcome measure)
Clinical Outcomes [ Time Frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791180 on ClinicalTrials.gov Archive Site
Surgical Outcomes [ Time Frame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Posterior Lateral Fusion (PLF) With Dynesys
Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System

Spondylolisthesis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Osteolytic spondylolisthesis
  • 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.
  • Pregnancy
  • Mental illness
  • 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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00791180
2006-002
No
Zimmer, Inc.
Zimmer, Inc.
Not Provided
Study Director: Jozef Murar, M.D. Zimmer Spine
Zimmer, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP