NCT02388022

A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

Detailed description

This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits. The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Degenerative Disc Disease	lumbar interbody with posterior screw and rod instrumentation

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2016-03-01
• First posted: 2015-03-13
• Last updated: 2016-08-10