PCM Cervical Disc System
Condition: Radiculopathy; Myelopathy
MeSH terms: Radiculopathy; Spinal Cord Diseases
Intervention: Anterior Cervical Discectomy and Fusion (ACDF); PCM Cervical Disc
Intervention description: Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1; PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved
      investigational device exemption (IDE) clinical trial conducted in the United States to
      evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and
      anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with
      adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a
      degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical
      trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM
      Cervical Disc or ACDF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years;

          -  Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;

          -  Symptomatic at only one level from C3-C4 to C7-T1;

          -  Unresponsive to non-operative treatment for six weeks, or has the presence of
             progressive symptoms or signs of nerve root/spinal cord compression in the face of
             conservative treatment;

          -  Baseline NDI score of ≥30/100;

          -  Radiographically determined pathology at level to be treated correlating to primary
             symptoms, including at least one of the following: decreased disc height, degenerative
             spondylosis on CT or MRI, or disc herniation;

          -  Appropriate for treatment using an anterior surgical approach, including having no
             more than one previous anterior surgical approach to the cervical spine;

          -  Ability and willingness to comply with follow-up regimen; and

          -  Written informed consent given by subject or subject's legally authorized
             representative.

        Exclusion Criteria:

          -  Infection at the site of surgery;

          -  History of, or anticipated treatment for, active systemic infection, including HIV
             infection or hepatitis C;

          -  Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy
             with less than one-third facetectomy at any level, or (2) a successful single-level
             anterior cervical fusion;

          -  More than one immobile vertebral level between C1-T1 from any cause, including but not
             limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior
             cervical spinal fusions;

          -  Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous
             cervical spine injury;

          -  Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy
             justifying the need for surgical intervention;

          -  Radiographic confirmation of severe facet joint disease or degeneration.

          -  Osteoporosis:

          -  Severe diabetes mellitus requiring daily insulin management;

          -  Active malignancy: a history of any invasive malignancy (except non-melanoma skin
             cancer), unless the patient has been treated with curative intent and there have been
             no clinical signs or symptoms of the malignancy for at least 5 years;

          -  Tumor as source of symptoms;

          -  Symptomatic DDD or significant cervical spondylosis at two or more levels;

          -  Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;

          -  Severe myelopathy to the extent that the patient is wheelchair bound;

          -  Pregnant (verified in patients of childbearing potential by a negative urine pregnancy
             test when preadmission testing is obtained), or interested in becoming pregnant during
             the duration of the study;

          -  Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid
             arthritis; ankylosing spondylitis);

          -  Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is
             likely anticipated within 6 months after the cervical randomized procedure;

          -  Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that
             surgical consideration is likely anticipated within 6 months after the cervical
             randomized procedure;

          -  Previous spine surgery within the 6 months preceding the cervical randomized
             procedure;

          -  Current or recent history of substance abuse (drug or alcohol);

          -  Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. over
             ideal body weight;

          -  Currently using, or planning to use, bone growth stimulators in the cervical spine;

          -  Use of any other investigational drug or medical device within the last 30 days prior
             to surgery

          -  Currently a prisoner; or

          -  Currently pursuing personal litigation related to the neck or cervical spine injury;
             however, involvement in worker's compensation related litigation is not a required
             exclusion.