An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

Cervical Spondylosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814825
• Other study ID #: DSS-2015-01
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: April 15, 2021

Study information

• Verified date: May 2021
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 15, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spondylosis
• Degenerative Intervertebral Discs
• Herniated Disc
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spondylosis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	An independent radiologist will review films to determine fusion	12 Months
Secondary	VAS (Visual Analog Scale)	Patient neck and arm pain reported on a VAS	12 Months
Secondary	NDI (Neck Disability Index)	Functional success based on results from the NDI	12 Months
Secondary	SF-12	Quality of life using SF-12 questionnaire	12 Months
Secondary	OR (Operating Room) Time	Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) using ViviGen	0 Days
Secondary	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
Secondary	Return to Work	How many patients return to work after having their two or three level ACDF using ViviGen	12 Months
Secondary	Adverse Events	Rate of adverse events (AEs)	12 Months
Secondary	Time to Fusion	Time to fusion as assessed by plain films	12 Months