An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
- Conditions
- Herniated DiscCervical SpondylosisDegenerative 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment:
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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)
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Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine
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Skeletally mature adults between 21 and 75 years of age
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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.
Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation:
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Posterior instrumentation necessary at same levels being treated
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Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
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Instability associated with cervical spine trauma
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Acute or chronic systemic or localized spinal infections
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Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
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History of previous cervical fusion surgery at greater than one level
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Previous pseudoarthrosis at any level of the cervical spine
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Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study
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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
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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)
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Immune compromised subjects
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Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy)
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Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia)
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History of pre-operative dysphagia
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Symptomatic shoulder pathologies under active treatment
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Known sensitivity to device materials
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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:
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Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
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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)