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OpenTrials
Completed

NCT Number: NCT01972256

A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

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).

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Key information

Conditions

Pseudoarthrosis Bone Diseases Degenerative Disc Disease (DDD) Fractures, Bone Fractures, Ununited Intervertebral Disc Degeneration Musculoskeletal Diseases Pseudarthrosis Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foundation for Orthopaedic Research and Education, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Efficacy

    Time frame: Assessed at 2 years post-op or greater

    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.

Secondary outcomes

  1. Safety

    Time frame: 2 years post-op

    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.

Other outcomes

  1. Additional Secondary Endpoint: Efficacy

    Time frame: Assessed at 2 years post-op

    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.

Sponsors and collaborators

Lead sponsor

Baxano Surgical, Inc.

Industry

Registry information

Official study title

Prospective Multicenter Clinical Evaluation of Fusion

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2013
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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