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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Degenerative Spondylolisthesis, Lumbar Spondylosis, Lumbar Spondylolisthesis

Intervention / Treatment
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* Device: Conduit Titanium Interbody Graft
* Device: Concorde Bullet Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conduit Interbody device<br>The Conduit Titanium Interbody Graft will be compared to the Concorde Bullet Device group for PLIF and TLIF. | Device: Conduit Titanium Interbody Graft<br>* The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.<br>|
| Concorde Bullet Device<br>The control group is patients with degenerative spondylotic disease undergoing either one level or two level fusions with Concorde Bullet Device interbody device. | Device: Concorde Bullet Device<br>* This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate | a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate | 1 year and at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar fusion