NCT03928041

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Invibio Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease Lumbar
• Spondylolisthesis, Grade 1

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-27
• Primary completion: 2023-05-22
• Completion: 2023-09-25
• First posted: 2019-04-25
• Last updated: 2025-04-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study