Clinical trial NCT05993195: Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion
Official title: Comparative Analysis of Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Spondylolisthesis
Lumbar Spondylosis
Lumbar Spondylolisthesis
Keywords: lumbar fusion
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation rate
timeFrame: 1 year and at 2 years
Secondary outcomes:
measure: Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
timeFrame: 2 years
Other outcomes:
measure: Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
timeFrame: 1 year and 2 years
measure: EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
timeFrame: 1 year and 2 years
measure: ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
timeFrame: 1 year and 2 years
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Robert G Whitmore, MD, FAANS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Hospital & Medical Center
name: Edilin Lopez, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.