Status:
COMPLETED
Post-Approval Clinical Trial of the PCM® Cervical Disc
Lead Sponsor:
NuVasive
Conditions:
Radiculopathy
Myelopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 cervic...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Patients enrolled in the PCM Cervical Disc IDE clinical study
- Patients willing and able to give informed consent
Exclusion
- Patients considered failure during the PCM Cervical Disc IDE clinical study
- Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT01905930
Start Date
April 1 2013
End Date
April 1 2015
Last Update
May 21 2015
Active Locations (18)
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1
Spine Group Beverly Hills
Beverly Hills, California, United States, 90212
2
Denver Spine
Greenwood Village, Colorado, United States, 80111
3
Midwest Orthopedic Associates at Rush
Chicago, Illinois, United States, 60612
4
Chicago Back Institute
Chicago, Illinois, United States, 60625