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

Last updated: July 1, 2024
Sponsor: Lahey Clinic
Overall Status: Completed

Phase

N/A

Condition

Spondylolisthesis

Ankylosing Spondylitis

Treatment

Conduit Titanium Interbody Graft

Concorde Bullet Device

Clinical Study ID

NCT05993195
20213046
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 levellumbar interbody fusion (either PLIF or TLIF)

  • All patients included will be index surgeries (no re-operations).

Exclusion

Exclusion Criteria:

  • Patients who improve with consecutive management and do not undergo lumbar fusionsurgery

  • Surgery performed in the thoracic or cervical spine

  • Surgery performed for tumor, infection, or trauma Patients who have an unstablefracture, tumor, and osteoporosis with T score exceeding -2.0

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Conduit Titanium Interbody Graft
Phase:
Study Start date:
March 12, 2021
Estimated Completion Date:
March 31, 2024

Study Description

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.

Connect with a study center

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

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