Status:
COMPLETED
Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
DePuy Synthes
Conditions:
Degenerative Spondylolisthesis
Lumbar Spondylosis
Eligibility:
All Genders
18+ years
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 reas...
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 understand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05993195
Start Date
March 12 2021
End Date
March 31 2024
Last Update
July 3 2024
Active Locations (1)
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1
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805