A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Prospective Multicenter Clinical Evaluation of Fusion

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).

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis; Spondylolisthesis; Pseudoarthrosis; 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education
  • Indiana
    • Indianapolis, Indiana, United States, 46032
      • Indiana Spine Group
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Bone and Joint Clinic of Baton Rouge
  • Michigan
    • Waterford, Michigan, United States, 48327
      • Michigan Spine Institute
  • Texas
    • College Station, Texas, United States, 77845
      • Brazos Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject candidates are those who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Previous transsacral fusion; Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Previous transforaminal lumbar interbody fusion; Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baxano Surgical, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Fractures, Ununited; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Pseudarthrosis
• Other Study ID Numbers: PR-0023