Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
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|ClinicalTrials.gov Identifier: NCT01485289|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : October 4, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
|Control, Posterolateral Fusion|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485289
|United States, North Carolina|
|Durham, North Carolina, United States, 27704|