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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-12

Study Completion Date

2024-03-31

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.

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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.

Conditions

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Degenerative Spondylolisthesis Lumbar Spondylosis Lumbar Spondylolisthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conduit Interbody device

The Conduit Titanium Interbody Graft will be compared to the Concorde Bullet Device group for PLIF and TLIF.

Conduit Titanium Interbody Graft

Intervention Type DEVICE

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

Concorde Bullet Device

The control group is patients with degenerative spondylotic disease undergoing either one level or two level fusions with Concorde Bullet Device interbody device.

Concorde Bullet Device

Intervention Type DEVICE

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

Interventions

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Conduit Titanium Interbody Graft

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

Intervention Type DEVICE

Concorde Bullet Device

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No