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PCM Cervical Disc System

NCT00578812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2015-07-07

Study results available
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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.

Conditions

  • Radiculopathy
  • Myelopathy

Interventions

DEVICE

Anterior Cervical Discectomy and Fusion (ACDF)

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

DEVICE

PCM Cervical Disc

PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-03-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578812 on ClinicalTrials.gov