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COMPLETED
NCT03928041
NA

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine

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 interbody spinal fusion using the EVOS Lumbar Interbody System.

Official title: A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2019-06-27

Completion Date

2023-09-25

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DEVICE

Device: EVOS Lumbar Interbody System (EVOS-HA)

All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis.

Locations (2)

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States