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COMPLETED
NCT04416321
NA

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

Sponsor: Invibio Ltd

View on ClinicalTrials.gov

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

DEVICE

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