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NCT03928041 · ClinicalTrials.gov registry record · NA

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

A NA study of Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, sponsored by Invibio.

Completed
Registry status
NA
Development phase
22
Enrollment target
2
Study locations

NCT03928041: Completed NA study of Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, sponsored by Invibio.

NCT03928041 is a NA study of Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1 that has completed, run by Invibio. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03928041, a NA study of Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, has completed, sponsored by Invibio.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target
2
Study locations

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.

Primary Outcome

Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is graded along the superior and inferior interfaces separately in 25% increments.

Interventions

  • DEVICE Device: EVOS Lumbar Interbody System (EVOS-HA)

Study Locations (2)

North Carolina

  • OrthoCarolina Research Institute - Charlotte

Pennsylvania

  • Thomas Jefferson University Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2019-06-27
Est. Completion 2023-09-25
Phase NA
Invibio

4 total trials

What the finished NCT03928041 record still lists

NCT03928041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Degenerative Disc Disease Lumbar appearing as the primary indexed condition, and to 1 intervention - of which Device: EVOS Lumbar Interbody System (EVOS-HA) is the first listed.

NCT03928041 reports a single indexed study location in North Carolina, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03928041 about?

NCT03928041 is a clinical study titled "A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine". 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.

What is the current status of trial NCT03928041?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2019-06-27. Estimated completion is 2023-09-25.

What conditions does trial NCT03928041 study?

This clinical trial studies the following conditions: Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1.

What interventions are being tested in trial NCT03928041?

The interventions under investigation include: Device: EVOS Lumbar Interbody System (EVOS-HA) (DEVICE).

Who is sponsoring clinical trial NCT03928041?

This trial is sponsored by Invibio, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03928041 being conducted?

This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Degenerative Disc Disease Lumbar

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03928041's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03928041, the US trial registry maintained by the National Library of Medicine. NCT03928041 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.