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
  Purpose

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
Spondylolisthesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Clinical Outcomes [ Time Frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical Outcomes [ Time Frame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: March 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791180

Locations
United States, Texas
Foundation Surgical Hospital
Houston, Texas, United States, 77074
Sponsors and Collaborators
Zimmer, Inc.
Investigators
Study Director: Jozef Murar, M.D. Zimmer Spine
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00791180     History of Changes
Other Study ID Numbers: 2006-002
Study First Received: November 13, 2008
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:
dynamic stabilization
Dynesys
fusion success
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:
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 20, 2014