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

NCT05993195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-07-03

No results posted yet for this 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.

Conditions

  • Degenerative Spondylolisthesis
  • Lumbar Spondylosis
  • Lumbar Spondylolisthesis

Interventions

DEVICE

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.

DEVICE

Concorde Bullet Device

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

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Robert G Whitmore, MD, FAANS · Lahey Hospital & Medical Center

  • Edilin Lopez, MD · Lahey Hospital & Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2023-12-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993195 on ClinicalTrials.gov