At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM® Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: 2 Year Results From the US IDE Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Anterior Cervical Discectomy and Fusion (ACDF) and PCM Cervical Disc for Radiculopathy and Myelopathy. Completed, enrolled 494 participants across 23 sites.
Detailed 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.
Study Details
Timeline
Interventions
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