Comparative Analysis of Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lahey Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reoperation rate
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Reoperation rate
Time Frame: 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 Outcomes
- Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion(2 years)