Cervical Spondylosis, Degenerative Intervertebral Discs, Herniated Disc
Conditions
Keywords
ViviGen, ACDF, Cervical
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.
Interventions
OTHERViviGen
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).
Sponsors
DePuy Spine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 12 Months | An independent radiologist will review films to determine fusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analog Scale) | 12 Months | Patient neck and arm pain reported on a VAS |
| NDI (Neck Disability Index) | 12 Months | Functional success based on results from the NDI |
| SF-12 | 12 Months | Quality of life using SF-12 questionnaire |
| OR (Operating Room) Time | 0 Days | Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) 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 |
| Return to Work | 12 Months | How many patients return to work after having their two or three level ACDF using ViviGen |
| Adverse Events | 12 Months | Rate of adverse events (AEs) |
| Time to Fusion | 12 Months | Time to fusion as assessed by plain films |
Outcome results
None listed