Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion

Lahey Clinic100 enrolled

Overview

The purpose of this early study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

The demand for lumbar fusion continues to rise with the growing and aging population. Additionally, new and innovative technologies continue to bring new devices to the market. However, our understanding of how emerging constructs compare with existing technology is lacking. The purpose of this study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device in lumbar fusion, one or two levels between L2-S1 will be included. Both transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) approaches will be included in the patient cohort. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Degenerative Spondylolisthesis Lumbar Spondylosis Lumbar Spondylolisthesis

Interventions

Conduit Titanium Interbody GraftDEVICE

The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.

Concorde Bullet DeviceDEVICE

This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease, either spondylosis, and/or spondylolisthesis * who have failed conservative management of at least 6 weeks requiring 1 or 2 level lumbar interbody fusion (either PLIF or TLIF) * All patients included will be index surgeries (no re-operations). Exclusion Criteria: * Patients who improve with consecutive management and do not undergo lumbar fusion surgery * Surgery performed in the thoracic or cervical spine * Surgery performed for tumor, infection, or trauma Patients who have an unstable fracture, tumor, and osteoporosis with T score exceeding -2.0

Locations (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

Reoperation rate

a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate

Time frame: 1 year and at 2 years

Secondary Outcomes

Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

Assessment of surgical variables, such as type of bone graft or bone graft extenders (including ViviGen, bone morphogenetic protein (BMP), tricalcium phosphate, local autograft, allograft, allograft chips, or demineralized bone matrix), on reoperations

Time frame: 2 years

Data from ClinicalTrials.gov

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