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An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

NCT02814825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-17

No results posted yet for this study

Summary

The purpose of this post-market study is to collect data on ViviGen and how its use affects fusion rates in the cervical spine when used as additional grafting material to fill the cervical spacer. The patient population of interest is patients who have already elected to undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.

Conditions

  • Cervical Spondylosis
  • Degenerative Intervertebral Discs
  • Herniated Disc

Interventions

OTHER

ViviGen

ViviGen Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 127 1.3(d).

Sponsors & Collaborators

  • DePuy Spine

    lead INDUSTRY

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2021-02-22
Completion
2021-04-15

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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 NCT02814825 on ClinicalTrials.gov