Performance of the Hedrocel(R) Cervical Fusion Device
Condition: Symptomatic Cervical Disc Disease
Intervention: Anterior Cervical Discectomy and Fusion; Anterior Cervical Discectomy and Fusion; Anterior Cervical Discectomy and Fusion
Intervention description: Implantation of Hedrocel; Implantation of Allograft; Implantation of Autograft
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Anterior Cervical Discectomy and Fusion,; Degenerative Disc Disease,; Cervical Spine,; Herniated Disc

Summary:

      The objective of this clinical investigation is to compare patients treated with Anterior
      Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a
      concurrent, randomized, control group receiving autologous iliac crest bone graft or
      allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with
      allograft or autologous bone graft.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient qualifies for ACDF based upon physical examination and medical history.
             The patient has single or two adjacent levels(s) symptomatic cervical disc disease
             (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc
             with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord
             compression due to herniated nucleus pulposus or osteophyte formation on the posterior
             vertebral endplates. Patients who are candidates for surgery based on radicular
             symptoms must have at least one month of conservative treatment prior to inclusion in
             the study.

          -  The patient has no history of previous anterior cervical fusion surgery at the
             involved levels.

          -  The patient has no history of previous cervical fusion surgery at the adjacent levels.

          -  The patient is willing and able to provide written informed consent.

          -  The patient is likely to complete the required follow-up.

        Exclusion Criteria:

          -  The patient is mentally compromised (e.g., under treatment for a psychiatric disorder
             or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other
             substance abuse for the previous 12 months.

          -  The patient has a neuromuscular disorder that would engender unacceptable risk of
             instability, implant fixation failure, or complications in postoperative care.

          -  The patient has a diagnosed systemic disease that requires the chronic administration
             of nonsteroidal anti-inflammatory and steroidal drugs.

          -  The patient has osteopenia to a degree that would contraindicate spinal
             instrumentation (borderline osteoporosis).

          -  The patient has osteoporosis to a degree that would contraindicate spinal
             instrumentation.

          -  The patient is unable or unwilling to attend postoperative follow-up visits.

          -  The patient has received an investigational drug within the previous six months or an
             investigational device within the previous 12 months.

          -  The patient has a spinal condition other than Cervical DDD based upon physical
             examination and medical history.

          -  The patient has an infection site distant from the involved levels that may spread to
             the involved levels hematogenously.

          -  The patient has insufficient bone stock to fix the component.

          -  The patient has a known sensitivity to metallic implants.

          -  The patient is a prisoner.

          -  The patient has a Body Mass Index (BMI) greater than or equal to 40.