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

NCT04416321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-29

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 spinal fusion using the Keos Lumbar Interbody Fusion Device.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Retrolisthesis

Interventions

DEVICE

Surgery with the Keos Lumbar Interbody Fusion Device

All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis

Sponsors & Collaborators

  • Keos LLC

    collaborator UNKNOWN

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Technomics Research

    collaborator INDUSTRY

  • Viedoc Technologies

    collaborator UNKNOWN

  • Invibio Ltd

    lead INDUSTRY

Principal Investigators

  • Louis A Marotti, M.D. PhD · Neurosurgical Associates of Lancaster

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2026-01-27
Completion
2026-01-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04416321 on ClinicalTrials.gov