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

NCT03928041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease Lumbar
  • Spondylolisthesis, Grade 1

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.

Sponsors & Collaborators

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Invibio Ltd

    lead INDUSTRY

Principal Investigators

  • Mark Kurd, M.D. · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2023-05-22
Completion
2023-09-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928041 on ClinicalTrials.gov