Posterior Lateral Fusion (PLF) With Dynesys

NCT ID: NCT00791180

Last Updated: 2011-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

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.

Conditions

Spondylolisthesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jozef Murar, M.D.

Role: STUDY_DIRECTOR

Zimmer Spine

Locations

Foundation Surgical Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

2006-002

Identifier Type: -

Identifier Source: org_study_id