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NCT03425682 · ClinicalTrials.gov registry record

ViBone in Cervical and Lumbar Spine Fusion

A clinical trial, sponsored by Elutia.

Completed
Registry status
118
Enrollment target

NCT03425682: Completed study, sponsored by Elutia.

NCT03425682 is a clinical trial that has completed, run by Elutia. The registered enrollment target is 118 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03425682 has completed, sponsored by Elutia.

COMPLETED
Registry status
118 participants
Enrollment target

Study Summary

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Primary Outcome

Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion ab

Interventions

  • OTHER ViBone

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2018-05-14
Est. Completion 2021-06-30
Elutia

10 total trials

What the finished NCT03425682 record still lists

NCT03425682 is an observational study that tracks outcomes without assigning an intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which ViBone is the first listed.

NCT03425682 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03425682 about?

NCT03425682 is a clinical study titled "ViBone in Cervical and Lumbar Spine Fusion". Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

What is the current status of trial NCT03425682?

This trial is currently completed. The enrollment target is 118 participants. The study started on 2018-05-14. Estimated completion is 2021-06-30.

What interventions are being tested in trial NCT03425682?

The interventions under investigation include: ViBone (OTHER).

Who is sponsoring clinical trial NCT03425682?

This trial is sponsored by Elutia, which has 10 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03425682, the US trial registry maintained by the National Library of Medicine. NCT03425682 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.