A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Spinal Stenosis Clinical Trial

Official title:

Prospective Multicenter Clinical Evaluation of Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972256
• Other study ID #: PR-0023
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: June 3, 2014
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Baxano Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Western Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Degenerative Disc Disease (DDD)
• Intervertebral Disc Degeneration
• Pseudarthrosis
• Pseudoarthrosis
• Spinal Stenosis
• Spondylolisthesis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baxano Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional Secondary Endpoint: Efficacy	Comparative Lordosis of L4-S1 at 24-months as determined by an independent orthopedic surgeon reviewer's interpretation of 24-month lateral (neutral) radiographs compared to baseline.	Assessed at 2 years post-op	No
Primary	Efficacy	Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.	Assessed at 2 years post-op or greater	No
Secondary	Safety	Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.	2 years post-op	Yes