NCT00792129

MIS MiLIF Versus Open

A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.

Detailed description

This is a prospective, multi-center, non-randomized cohort design clinical study to evaluate the clinical outcomes of patients that have a minimally invasive lumbar interbody fusion (MiLIF) through the Atavi system compared to traditional unilateral open lumbar interbody fusion through a midline incision. the study will involve up to approximately 12 investigational sites and enroll up to 126 patients.

Conditions

• Chronic Low Back Pain
• Leg Pain

Interventions

Type	Name	Description
DEVICE	The Atavi System	The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument. The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used.

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-03-01
• Completion: 2009-06-01
• First posted: 2008-11-17
• Last updated: 2012-02-16

Locations

9 sites across 1 country: United States