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

Rachiotek LLC43 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Stenosis

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 This applies only if the patient was formally withdrawn from the study at that time.

Locations (1)

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) for Leg Pain

Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)