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A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
Sponsor: Invibio Ltd
Summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
Official title: A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2021-07-01
Completion Date
2026-01-27
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Surgery with the Keos Lumbar Interbody Fusion Device
All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis
Locations (1)
Neurosurgical Associates of Lancaster
Lancaster, Pennsylvania, United States