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

Degenerative Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05993195
• Other study ID #: 20213046
• Status: Active, not recruiting
• Start date: March 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Lumbar Spondylolisthesis
• Lumbar Spondylosis
• Spondylolisthesis
• Spondylosis

Intervention

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.
• Concorde Bullet Device
This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	DePuy Synthes

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion	Demographics, comorbidities, will be assessed including efficacy, safety, and fusion rates.; Demographics include the following: gender, age, race, BMI, weight (oz.), height (inches), ASA class, surgery level.; Comorbidities include the following: diabetes, heart failure, coronary artery disease, anxiety/depression, active smoker, pre-operative opioid use.	1 year and 2 years
Other	EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion	The EQ5D index scale is a 5-dimension standardized measurement of heath status developed by EuroQol. The EQ5D index is derived by applying a formula that consist of weights. It is calculated by assigning a numerical value to each response level (ie. 1 for "no problem", 3 for "extreme problem"/"unable to"). The EQ5D scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health scale).	1 year and 2 years
Other	ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion	The Oswestry Disability Index is a gold standard outcome measure that was designed to assess daily function for those who experience back pain. The questionnaire consists of 10 questions presented as a 6-Likert scale. For each section the total possible score is 5; the first statement marked would score=0; the last statement marked would score=5. Scores range from 0% to 100%.	1 year and 2 years
Primary	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	Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion	Assessment of surgical variables, such as type of bone graft or bone graft extenders (including ViviGen, bone morphogenetic protein (BMP), tricalcium phosphate, local autograft, allograft, allograft chips, or demineralized bone matrix), on reoperations	2 years