PCM Cervical Disc System
Condition: Radiculopathy; Myelopathy
MeSH terms: Radiculopathy; Spinal Cord Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.

      Patients were evaluated before surgery, during the operation, immediately after surgery, and
      then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The
      patients were recommended to have a physical therapy program for non-impact exercises and
      active range of motion exercises after surgery. Patients were also instructed to avoid
      repetitive cervical flexion and extension bending and lateral bending and rotation for 6
      weeks following surgery.

      The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any
      additional surgical procedures, and the neurological outcomes to those in the ACDF control
      group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients' pain
      and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the
      severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of
      life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient
      satisfaction questionnaire compared to the ACDF control group. In addition, the patients were
      evaluated using radiographic evaluations, including spinal range of motion, spinal disc
      height, device displacement or migration, spinal fusion status, and heterotopic ossification
      (abnormal bone formation).

      The primary endpoint of the IDE trial was a composite measure termed "overall success," which
      was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in
      neck disability index (NDI) from preoperative score; absence of reoperation, revision, or
      removal; maintenance or improvement in neurological status; and absence of radiographic or
      major complications during the 24-month follow-up period.

      On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM
      Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a
      degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy
      for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck
      pain, or myelopathy due to a single-level abnormality localized to the disc space, and
      manifested by at least one of the following conditions confirmed by radiographic imaging (CT,
      MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of
      osteophytes), and/or visible loss of disc height as compared to adjacent levels.
    

Intervention name(s): Anterior Cervical Discectomy and Fusion (ACDF); PCM Cervical Disc
Intervention type(s): Device; Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment