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.

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77074
      • Foundation Surgical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Outcomes	Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical Outcomes	Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Jozef Murar, M.D., Zimmer Spine

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (Estimate): November 14, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: fusion success; dynamic stabilization; Dynesys; 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: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 2006-002