CompletedNot Applicable

An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

100 participantsStarted 2016-06-01

Plain-language 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.

Who can participate

Age range21 Years – 75 Years

SexALL

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Inclusion criteria

✓. Diagnosed by the investigator with at least one (1) of the following:
✓. Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine
✓. Skeletally mature adults between 21 and 75 years of age
✓. Subjects, who, in the opinion of the Investigator, are able to understand the purpose of the study and are willing to return for all the required post-operative standard of care follow-up visits and have their data collected.

Exclusion criteria

✕. Posterior instrumentation necessary at same levels being treated
✕. Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
✕. Instability associated with cervical spine trauma
✕. Acute or chronic systemic or localized spinal infections
✕. Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
✕. History of previous cervical fusion surgery at greater than one level
✕. Previous pseudoarthrosis at any level of the cervical spine
✕. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study

What they're measuring

Fusion

Timeframe: 12 Months

Trial details

NCT IDNCT02814825

SponsorDePuy Spine

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-02-22

View on ClinicalTrials.gov More Cervical Spondylosis trials