NCT00759057

A Clinical Study of the Dynesys(R) Spinal System

A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.

Detailed description

The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.

Conditions

• Degenerative Spondylolisthesis or Retrolisthesis
• Spinal Stenosis
• Stenosing Lesion.

Interventions

Type	Name	Description
DEVICE	Posterior Pedicle Screw System	Implantation of Posterior Pedicle Screw System

Timeline

• Start date: 2003-03-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2008-09-25
• Last updated: 2012-06-28

Locations

26 sites across 1 country: United States