An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

NCT ID: NCT02814825

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2021-04-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ViviGen

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

ViviGen Cellular Bone Matrix

Eligibility Criteria

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)

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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DSS-2015-01

Identifier Type: -

Identifier Source: org_study_id