Status:
COMPLETED
Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
Lead Sponsor:
Rachiotek LLC
Conditions:
Spinal Stenosis
Eligibility:
All Genders
21+ years
Brief Summary
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Ap...
Eligibility Criteria
Inclusion
- Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.
Exclusion
- Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01485289
Start Date
August 1 2011
End Date
December 1 2012
Last Update
October 4 2016
Active Locations (1)
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1
Triangle Orthopedics
Durham, North Carolina, United States, 27704