NCT00726310

Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 202 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.

Detailed description

This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	SpineLink® , SpineLink® II	Spine plate system for lumbar spinal fusions

Timeline

• Start date: 2000-05-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2008-07-31
• Last updated: 2020-02-13

Locations

2 sites across 1 country: United States