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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Stabilimax | |||
| Control, Posterolateral Fusion |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Triangle Orthopedics | Durham | North Carolina | 27704 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |