Post-Approval Clinical Trial of the PCM® Cervical Disc

NuVasive

Status and phase: Completed; Phase 3

Conditions: Radiculopathy; Myelopathy

Treatments: Device: Anterior Cervical Discectomy and Fusion (ACDF); Device: PCM Cervical Disc

Study type: Interventional

Funder types: Industry

Identifiers

NCT01905930

NUVA-PCM-1101

Details and patient eligibility

About

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.

The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.

Full description

A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.

All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.

The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.

Enrollment: 494 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients enrolled in the PCM Cervical Disc IDE clinical study
• Patients willing and able to give informed consent

Exclusion criteria

• Patients considered failure during the PCM Cervical Disc IDE clinical study
• Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

494 participants in 2 patient groups

PCM Cervical Disc

Experimental group

Description:

Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1

Treatment:

Device: PCM Cervical Disc

Ant. Cervical Discectomy & Fusion(ACDF)

Active Comparator group

Description:

Patients enrolled in the IDE clinical study and treated with an 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

Treatment:

Device: Anterior Cervical Discectomy and Fusion (ACDF)