NCT01972256

A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Prospective Multicenter Clinical Evaluation of Fusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Baxano Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Detailed description

Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.

Conditions

• Pseudoarthrosis
• Spinal Stenosis
• Spondylolisthesis
• Degenerative Disc Disease (DDD)

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-10-30
• Last updated: 2014-06-04

Locations

5 sites across 1 country: United States