ViBone in Cervical and Lumbar Spine Fusion

Study Overview
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Brief Summary
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Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Detailed Description
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This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

Official Title
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A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

Conditions
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Cervical Spondylosis, Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus, Degenerative Disc Disease

Intervention / Treatment
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* Other: ViBone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-80 years of age For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7 For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1 Patient signed Consent Form with HIPAA Authorization Appropriate candidate for surgery Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available). Exclusion Criteria: Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.) Treatment with radiotherapy Acute or chronic systemic or localized spinal infections Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible. Inability to provide informed consent Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5). Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count. Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical Fusion - ACDF<br>Up to 50 patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. | Other: ViBone<br>* Viable Bone Allograft<br>|
| Lumbar Interbody Fusion<br>Up to 50 patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. | Other: ViBone<br>* Viable Bone Allograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Fusion rates for ViBone from surgical procedure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI | Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion | 12 months | 
| NDI | Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion | 12 months | 
| VAS | Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cervical Discectomy and Fusion (ACDF), Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF)