BIO4 Clinical Case Study: Cervical Spine
Condition: Degenerative Disc Disease; Trauma (Including Fractures); Spondylolisthesis
MeSH terms: Intervertebral Disc Degeneration; Spondylolisthesis
Intervention: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).; Aviator Anterior Cervical Plating System
Intervention description: The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.; The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Total cervical vertebrectomy; Partial cervical vertebrectomy; Failed previous fusion; Spinal stenosis; Tumor; Decompression of the spinal cord; Pseudoarthrosis; Curvatures; Deformities

Summary:

      The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients
      undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
      Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS
      Cervical Allograft (with graft window).
    

Eligibility criteria:

        Inclusion Criteria

          1. Age>18 years

          2. Scheduled 1 or 2-level ACDF spine surgery

          3. The capacity to provide informed consent.

          4. Subject has one or more of the following diagnoses:

               1. Degenerative Disc Disease (as defined by neck pain of discogenic origin with
                  degeneration of the disc confirmed by patient history and radiographic studies)

               2. Trauma (including fractures)

               3. Tumors

               4. Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

               5. Pseudoarthrosis

               6. Failed previous fusion

               7. Decompression of the spinal cord following total or partial cervical
                  vertebrectomy

               8. Spondylolisthesis

               9. Spinal stenosis

        Exclusion Criteria Patients with any of the following conditions will be excluded, or if
        enrolled and found to be ineligible and do not fit the inclusion criteria, will be
        withdrawn from the study.

          1. Patients with current or recent history of malignancy or infectious disease.

          2. The inability to provide informed consent.

          3. Subject has marked local inflammation

          4. Subject has any mental or neuromuscular disorder which would create an unacceptable
             risk of fixation failure or complications in postoperative care.

          5. Subject has a bone stock compromised by disease, infection or prior implantation which
             cannot provide adequate support and/or fixation to the devices.

          6. Subject has bone abnormalities preventing safe screw fixation.

          7. Subject has any open wounds.

          8. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or
             osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this
             condition may limit the degree of obtainable correction and/or the amount of
             mechanical fixation.

          9. Subject has a documented or suspected metal sensitivity.

         10. Subject is pregnant.

         11. Subject has anatomical structures or physiological performance that would interfere
             with implant utilization.

         12. Subject has inadequate tissue coverage over the operative site.

         13. Subject has 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.

         14. Note: The Aviator Anterior Cervical Plating System is not approved or intended for
             screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or
             lumbar spine. The surgeon must consider the levels of implantation, patient weight,
             patient activity level, and other patient conditions which may impact on the
             performance of the system.