An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

NCT02814825 | Completed

• 1 other identifier: DSS-2015-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ViviGen; ACDF; Cervical

Outcome Measures

Primary Outcomes (1)

• Fusion

  An independent radiologist will review films to determine fusion

  12 Months

Secondary Outcomes (8)

• VAS (Visual Analog Scale)

  12 Months

• NDI (Neck Disability Index)

  12 Months

• SF-12

  12 Months

• OR (Operating Room) Time

  0 Days

• Length of Hospital Stay

  12 Months

Study Arms (1)

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

Interventions

ViviGen OTHER

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).

Also known as: ViviGen Cellular Bone Matrix

ViviGen

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• DePuy Spine: lead

MeSH Terms

Conditions

Spondylosis; Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: February 22, 2021
• Study Completion: April 15, 2021
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share