A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

Prospective Multicenter Clinical Evaluation of Fusion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01972256

Enrollment

Registered

2013-10-30

Start date

2013-04-30

Completion date

2014-02-28

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	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

Measure	Time frame	Description
Safety	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

Measure	Time frame	Description
Additional Secondary Endpoint: Efficacy	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.

Countries

United States

Outcome results