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

Spondylolisthesis, Grade 1 Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment. ;

Related Conditions & MeSH terms

• Degenerative Disc Disease Lumbar
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Spondylolisthesis, Grade 1

• NCT number: NCT03928041
• Study type: Interventional
• Source: Invibio Ltd
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Completion date: September 25, 2023