Posterior Lateral Fusion (PLF) With Dynesys

Spondylolisthesis Clinical Trial

Official title:

Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791180
• Other study ID #: 2006-002
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: September 28, 2011
• Start date: March 2006
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylolisthesis

Locations

Country	Name	City	State
United States	Foundation Surgical Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcomes		Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months	No
Secondary	Surgical Outcomes		Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months	No