Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Visual Analog Scale (VAS) for Leg Pain [ Time Frame: Minimum 24 months post procedure ]
Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)
Zurich Claudication Questionnaire (ZCQ) [ Time Frame: Minimum 24 months post procedure ]
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
Major Device Related (MDR) Complications [ Time Frame: Minimum 24 months post procedure ]
Patient experiences no major device-related complications
Revision, Reoperation, or Removal [ Time Frame: Minimum 24 months post procedure ]
The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
Secondary Outcome Measures
Oswestry Disability Index (ODI) [ Time Frame: Minimum 24 months post procedure ]
Changes from baseline in function scores (Oswestry Disability Index)
Presence (control) or Absence (Stabilimax)of fusion [ Time Frame: Minimum 24 months post procedure ]
Presence (control patients) or absence (Stabilimax NZ® patients) of fusion at 24-months post procedure
Adverse Events (AE) [ Time Frame: Minimum 24 months post procedure ]
safety will be assessed by quantification of the incidence of all adverse events observed during the study period by type.
Physician Satisfaction Scale [ Time Frame: Immediately post procedure ]
Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.