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

Lahey Health

Status: Completed

Conditions: Lumbar Spondylosis; Lumbar Spondylolisthesis; Degenerative Spondylolisthesis

Treatments: Device: Conduit Titanium Interbody Graft; Device: Concorde Bullet Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05993195

20213046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Conduit Interbody device

Description:

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

Treatment:

Device: Conduit Titanium Interbody Graft

Concorde Bullet Device

Description:

The control group is patients with degenerative spondylotic disease undergoing either one level or two level fusions with Concorde Bullet Device interbody device.

Treatment:

Device: Concorde Bullet Device