Cervical SpondylosisNCT02814825
An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
An observational study of Cervical Spondylosis and Degenerative Intervertebral Discs, run by DePuy Spine.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cervical Spondylosis, Degenerative Intervertebral Discs, Herniated Disc
- What is being tested?
- ViviGen
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:
- 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.
Who cannot join
- Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation:
- 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)
Show all 21Show fewer
- 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
- Known sensitivity to device materials
- 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:
- Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
- Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP
About this study
Official title: 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.
- Being tested
- ViviGen
- Keywords
- ViviGen, ACDF, Cervical
- Medical subject headings
- Spondylosis, Intervertebral Disc Degeneration, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViviGenOther
Also called ViviGen Cellular Bone Matrix
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ViviGen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
An independent radiologist will review films to determine fusion
Measured: 12 Months
Secondary outcomes (8)
VAS (Visual Analog Scale)
Patient neck and arm pain reported on a VAS
Measured: 12 Months
NDI (Neck Disability Index)
Functional success based on results from the NDI
Measured: 12 Months
SF-12
Quality of life using SF-12 questionnaire
Measured: 12 Months
OR (Operating Room) Time
Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) using ViviGen
Measured: 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
Measured: 12 Months
Return to Work
How many patients return to work after having their two or three level ACDF using ViviGen
Measured: 12 Months
Adverse Events
Rate of adverse events (AEs)
Measured: 12 Months
Time to Fusion
Time to fusion as assessed by plain films
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion22 Feb 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814825
- Sponsor's protocol ID
- DSS-2015-01
- Status last verified
- Feb 2026
- First submitted
- 22 Jun 2016
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02814825
- Acronym / sponsor ID
- DSS-2015-01
- Keywords
- ViviGen, ACDF, Cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ViviGen | – | Other: ViviGenPatients 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:
- 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.
Key exclusion criteria (21 listed)
- Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViviGenAlso: ViviGen Cellular Bone MatrixViviGen 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 | ViviGen |
Primary outcome
Fusion
Time frame: 12 Months
An independent radiologist will review films to determine fusion
8 secondary outcomes
VAS (Visual Analog Scale)
Time frame: 12 Months
NDI (Neck Disability Index)
Time frame: 12 Months
SF-12
Time frame: 12 Months
OR (Operating Room) Time
Time frame: 0 Days
Length of Hospital Stay
Time frame: 12 Months
Return to Work
Time frame: 12 Months
Adverse Events
Time frame: 12 Months
Time to Fusion
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis and Degenerative Intervertebral Discs, run by DePuy Spine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.