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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04416321
Study type Interventional
Source Invibio Ltd
Contact Karen Robson
Phone +44 7765 220492
Email karen.robson@invibio.com
Status Recruiting
Phase N/A
Start date July 1, 2021
Completion date January 2026
View Details
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