A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Completed

Conditions studied: Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)

In brief

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).

Key facts

Study ID

NCT01972256

Run by

Baxano Surgical, Inc.

People needed

60

Starts

2013-04-01

Expected to finish

2014-02-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult 18 years of age or older
• Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
• Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
• Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery

You may not qualify if…

• Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
• Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery

Where it is running

• Foundation for Orthopaedic Research and Education — Tampa, Florida, United States
• Indiana Spine Group — Indianapolis, Indiana, United States
• Bone and Joint Clinic of Baton Rouge — Baton Rouge, Louisiana, United States
• Michigan Spine Institute — Waterford, Michigan, United States
• Brazos Spine — College Station, Texas, United States

Full record on ClinicalTrials.gov

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