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

NCT03928041•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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is the subject aged 18 years of age or older and skeletally mature?
•Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
•Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
•Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
•Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
•Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief?
•If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months?
•Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups?
•Is the subject able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained?

Exclusion Criteria

•Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures?
•Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years?
•Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator?
•Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised?
•Does the subject have a known allergy to the material used in the instrumentation?
•Does the subject have evidence of an active infection and/or do they have any condition that would compromise their participation and follow-up in this clinical study?
•Is the subject receiving any drug treatment that may affect bone metabolism?
•If the subject is female, are they pregnant or lactating?
•Is the subject a current smoker, or have they stopped smoking less than 6 months ago?
•Is the subject a known drug or alcohol abuser or do they have a baseline opioid use greater than 30 mg of morphine equivalent/day or do they have psychological disorders that could affect follow-up care or treatment outcomes?
+1 more criteria

Locations (2)

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 27, 2019

Primary Completion Date

May 22, 2023

Completion Date

September 25, 2023

Last Updated

April 30, 2025

Enrollment

ACTUAL participants

Conditions

Degenerative Disc Disease LumbarSpondylolisthesis, Grade 1

Interventions

Device: EVOS Lumbar Interbody System (EVOS-HA)

DEVICE

CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

NCT07137559

Chronic Back PainDegenerative Disc Disease Lumbar

View study

COMPLETED

FLXfit Post Market Outcome Study Protocol

NCT02882243

Degenerative Disc Disease Lumbar

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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