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

NCT05993195 | Completed DMC FDA Device

• 1 other identifier: 20213046
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lumbar fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Other Outcomes (3)

• Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

  1 year and 2 years

• EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

  1 year and 2 years

• ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

  1 year and 2 years

Study Arms (2)

Conduit Interbody device

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

Device: Conduit Titanium Interbody Graft

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.

Device: Concorde Bullet Device

Interventions

Conduit Titanium Interbody Graft DEVICE

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

Conduit Interbody device

Concorde Bullet Device DEVICE

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

Concorde Bullet Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion of interbody devices resulted in higher of lumbar fusion, however, new devices have not been fully evaluated clinical and radiographically in terms of overall outcomes.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead
• DePuy Synthes: collaborator

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Publications (5)

• Greiner-Perth R, Boehm H, Allam Y, Elsaghir H, Franke J. Reoperation rate after instrumented posterior lumbar interbody fusion: a report on 1680 cases. Spine (Phila Pa 1976). 2004 Nov 15;29(22):2516-20. doi: 10.1097/01.brs.0000144833.63581.c1.

  PMID: 15543064 BACKGROUND

• Irmola TM, Hakkinen A, Jarvenpaa S, Marttinen I, Vihtonen K, Neva M. Reoperation Rates Following Instrumented Lumbar Spine Fusion. Spine (Phila Pa 1976). 2018 Feb 15;43(4):295-301. doi: 10.1097/BRS.0000000000002291.

  PMID: 28614279 BACKGROUND

• Choudhri TF, Mummaneni PV, Dhall SS, Eck JC, Groff MW, Ghogawala Z, Watters WC 3rd, Dailey AT, Resnick DK, Sharan A, Wang JC, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 4: radiographic assessment of fusion status. J Neurosurg Spine. 2014 Jul;21(1):23-30. doi: 10.3171/2014.4.SPINE14267.

  PMID: 24980581 BACKGROUND

• Carreon LY, Djurasovic M, Glassman SD, Sailer P. Diagnostic accuracy and reliability of fine-cut CT scans with reconstructions to determine the status of an instrumented posterolateral fusion with surgical exploration as reference standard. Spine (Phila Pa 1976). 2007 Apr 15;32(8):892-5. doi: 10.1097/01.brs.0000259808.47104.dd.

  PMID: 17426635 BACKGROUND

• Carreon LY, Glassman SD, Schwender JD, Subach BR, Gornet MF, Ohno S. Reliability and accuracy of fine-cut computed tomography scans to determine the status of anterior interbody fusions with metallic cages. Spine J. 2008 Nov-Dec;8(6):998-1002. doi: 10.1016/j.spinee.2007.12.004. Epub 2008 Feb 14.

  PMID: 18280214 BACKGROUND

MeSH Terms

Conditions

Spondylosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Study Officials

• Robert G Whitmore, MD, FAANS

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Edilin Lopez, MD

  Lahey Hospital & Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 15, 2023
• Study Start: March 12, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: The data is accessed only by the study sponsor.

Locations

US (1)