Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study

Completed

Conditions studied: Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT01485289

Run by

Rachiotek LLC

People needed

43

Starts

2011-08-01

Expected to finish

2012-12-01

Last updated by the study team

2016-10-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 This applies only if the patient was formally withdrawn from the study at that time.

Where it is running

• Triangle Orthopedics — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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