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

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.

Study Overview

• Status: Completed
• Conditions: Herniated Disc; Cervical Spondylosis; Degenerative Intervertebral Discs
• Intervention / Treatment: Other: ViviGen

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male or female patients with cervical spondylosis, degenerative disc disease (DDD), or herniated nucleus pulposus (HNP) who are to receive cervical spine surgery with anterior column support at two or three contiguous levels (C2-C7)

Description

Inclusion Criteria:

Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:

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:

Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation:

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)
11. Immune compromised subjects
12. Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy)
13. Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia)
14. History of pre-operative dysphagia
15. Symptomatic shoulder pathologies under active treatment
16. Known sensitivity to device materials

17. Subjects who, in the opinion of the Investigator, have any other existing condition that would compromise their participation and follow-up in this clinical study

    Intraoperative exclusion criteria:

18. Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
19. Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ViviGen; Patients undergoing a two or three level ACDF using ViviGen Cellular Bone Matrix in conjunction with cervical allograft spacers and DePuy Synthes anterior cervical plate systems.	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).; Other Names: ViviGen Cellular Bone Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	An independent radiologist will review films to determine fusion	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual Analog Scale)	Patient neck and arm pain reported on a VAS	12 Months
NDI (Neck Disability Index)	Functional success based on results from the NDI	12 Months
SF-12	Quality of life using SF-12 questionnaire	12 Months
OR (Operating Room) Time	Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) using ViviGen	0 Days
Length of Hospital Stay	Length of time the patient remains in the hospital before being discharged after their two or three level ACDF using ViviGen	12 Months
Return to Work	How many patients return to work after having their two or three level ACDF using ViviGen	12 Months
Adverse Events	Rate of adverse events (AEs)	12 Months
Time to Fusion	Time to fusion as assessed by plain films	12 Months

Collaborators and Investigators

• Sponsor: DePuy Spine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cervical; ACDF; ViviGen
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement; Spondylosis; Intervertebral Disc Degeneration
• Other Study ID Numbers: DSS-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO