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An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix | Clinical Trials | Clareo Health

COMPLETED

An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

A Multi-Center, Prospective, Single-Arm Study of Patients Undergoing a Two or Three Level ACDF Using ViviGen Cellular Bone Matrix in Conjunction With Cervical Allograft Spacers and DePuy Synthes Spine Anterior Cervical Plate Systems

NCT02814825•DePuy Spine

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed by the investigator with at least one (1) of the following:
•* Symptomatic cervical spondylosis;
•* Degenerative disc disease (DDD), defined as discogenic pain with degeneration of the disc confirmed by history and imaging studies;
•* Herniated nucleus pulposus (HNP)
•2. Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine
•3. Skeletally mature adults between 21 and 75 years of age
•4. 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

•1. Posterior instrumentation necessary at same levels being treated
•2. Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
•3. Instability associated with cervical spine trauma
•4. Acute or chronic systemic or localized spinal infections
•5. Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
•6. History of previous cervical fusion surgery at greater than one level
•7. Previous pseudoarthrosis at any level of the cervical spine
•8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study
•9. Severe osteoporosis (per the Investigator's diagnosis or per a T-score greater than or equal to 2.5 SD below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a cervical plate system
•10. Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA)
+9 more criteria

Key Dates

Start Date

June 1, 2016

Primary Completion Date

February 22, 2021

Completion Date

April 15, 2021

Last Updated

February 17, 2026

Enrollment

100

ACTUAL participants

Conditions

Cervical SpondylosisDegenerative Intervertebral DiscsHerniated Disc

Interventions

ViviGen

OTHER

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Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

Inclusion Criteria

Exclusion Criteria

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

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