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

Study Overview
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Brief Summary
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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.

Official Title
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Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001

Conditions
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Spinal Stenosis

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 This applies only if the patient was formally withdrawn from the study at that time.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Investigational Stabilimax<br> | |
| Control, Posterolateral Fusion<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Minimum 24 months post procedure | 
| Zurich Claudication Questionnaire (ZCQ) | Clinically significant improvement from baseline defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both Symptom Severity(SS) and Physical Function (PF) scores | Minimum 24 months post procedure | 
| Major Device Related (MDR) Complications | Patient experiences no major device-related complications | Minimum 24 months post procedure | 
| Revision, Reoperation, or Removal | The treated level did not require surgical revision, reoperation, removal, or supplemental fixation. | Minimum 24 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Changes from baseline in function scores (Oswestry Disability Index) | Minimum 24 months post procedure | 
| Presence (control) or Absence (Stabilimax)of fusion | Presence (control patients) or absence (Stabilimax NZ® patients) of fusion at 24-months post procedure | Minimum 24 months post procedure | 
| Adverse Events (AE) | safety will be assessed by quantification of the incidence of all adverse events observed during the study period by type. | Minimum 24 months post procedure | 
| Physician Satisfaction Scale | Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales. | Immediately post procedure |