Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2011 |
| End Date: | March 2012 |
Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
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 Applied Spine Technologies Inc . The Applied Spine assets, including the
clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased
their funding of the trial, a number of enrolled patients had not yet completed the two year
follow-up visit defined as the study endpoint in the clinical investigation plan. No
additional patient treatment is required to complete the study. Rachiotek has interest in
pursuing IDE approval for a new study and the information collected in this study is
essential for supporting the new Investigational Device Exemption application.
in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the
now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the
clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased
their funding of the trial, a number of enrolled patients had not yet completed the two year
follow-up visit defined as the study endpoint in the clinical investigation plan. No
additional patient treatment is required to complete the study. Rachiotek has interest in
pursuing IDE approval for a new study and the information collected in this study is
essential for supporting the new Investigational Device Exemption application.
Inclusion Criteria:
- 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 Criteria:
- 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withdrawn from the study at that time.
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