Clinical trial NCT02814825: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylosis
Degenerative Intervertebral Discs
Herniated Disc
Keywords: ViviGen
ACDF
Cervical
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fusion
timeFrame: 12 Months
Secondary outcomes:
measure: VAS (Visual Analog Scale)
timeFrame: 12 Months
measure: NDI (Neck Disability Index)
timeFrame: 12 Months
measure: SF-12
timeFrame: 12 Months
measure: OR (Operating Room) Time
timeFrame: 0 Days
measure: Length of Hospital Stay
timeFrame: 12 Months
measure: Return to Work
timeFrame: 12 Months
measure: Adverse Events
timeFrame: 12 Months
measure: Time to Fusion
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
References: