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

Completed

• Conditions: Lumbar Spondylolisthesis; Degenerative Spondylolisthesis; Lumbar Spondylosis
• Interventions: Device: Conduit Titanium Interbody Graft; Device: Concorde Bullet Device

• Registration Number: NCT05993195
• Lead Sponsor: Lahey Clinic

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.

Study Timeline

• Study Start: 2021-03-12
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reoperation rate	1 year and at 2 years	a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate

Secondary Outcome Measures

Name	Time	Method
Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion	2 years	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

Trial Locations

Locations (1)

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States