An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

Completed

• Conditions: Herniated Disc; Cervical Spondylosis; Degenerative Intervertebral Discs

• Registration Number: NCT02814825
• Lead Sponsor: DePuy Spine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2021-02-22
• Study Completion: 2021-04-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	12 Months	An independent radiologist will review films to determine fusion

Secondary Outcome Measures

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