Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.

Detailed Description
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This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.

Official Title
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Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Conditions
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Cervical Disc Degenerative Disorder

Intervention / Treatment
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* Biological: Cellentra VCBM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System. The subject is 18 years of age or older. The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner. The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies. The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. Exclusion Criteria: Subject has an active local or systemic infection. Subject is morbidly obese, defined as a BMI greater than 40. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. Subject has inadequate tissue coverage over the operative site. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Any previous cervical spinal surgery. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.) or immunocompromised. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study. Subject is currently involved in another investigational drug or device study that could confound study data. Subject is a prisoner. Subject has a metal sensitivity/foreign body sensitivity. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellentra VCBM<br>Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects. | Biological: Cellentra VCBM<br>* Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NDI From Baseline | Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%. | 12 months after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Radiographic Success at 24 Months | Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system: Grade I (definite) - Fused with remodeling and trabeculae Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse. Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellentra ACDF