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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViviGen | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | An independent radiologist will review films to determine fusion | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (Visual Analog Scale) | Patient neck and arm pain reported on a VAS | 12 Months |
| NDI (Neck Disability Index) | Functional success based on results from the NDI |
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Inclusion Criteria:
Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:
Diagnosed by the investigator with at least one (1) of the following:
Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine
Skeletally mature adults between 21 and 75 years of age
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:
Posterior instrumentation necessary at same levels being treated
Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
Instability associated with cervical spine trauma
Acute or chronic systemic or localized spinal infections
Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
History of previous cervical fusion surgery at greater than one level
Previous pseudoarthrosis at any level of the cervical spine
Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study
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
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)
Immune compromised subjects
Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy)
Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia)
History of pre-operative dysphagia
Symptomatic shoulder pathologies under active treatment
Known sensitivity to device materials
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:
Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP
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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)
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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|
| 12 Months |
| SF-12 | Quality of life using SF-12 questionnaire | 12 Months |
| OR (Operating Room) Time | Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) using ViviGen | 0 Days |
| 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 |
| Return to Work | How many patients return to work after having their two or three level ACDF using ViviGen | 12 Months |
| Adverse Events | Rate of adverse events (AEs) | 12 Months |
| Time to Fusion | Time to fusion as assessed by plain films | 12 Months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |