Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
This study is currently recruiting participants.
Verified December 2011 by Rachiotek LLC
Sponsor:
Rachiotek LLC
Information provided by (Responsible Party):
Rachiotek LLC
ClinicalTrials.gov Identifier:
NCT01485289
First received: September 29, 2011
Last updated: December 1, 2011
Last verified: December 2011
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Purpose
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.
| Condition |
|---|
|
Spinal Stenosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001 |
Resource links provided by NLM:
Further study details as provided by Rachiotek LLC:
Primary Outcome Measures:
- Visual Analog Scale (VAS) for Leg Pain [ Time Frame: Minimum 24 months post procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Patient experiences no major device-related complications
- Revision, Reoperation, or Removal [ Time Frame: Minimum 24 months post procedure ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Changes from baseline in function scores (Oswestry Disability Index)
- Presence (control) or Absence (Stabilimax)of fusion [ Time Frame: Minimum 24 months post procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Investigational Stabilimax |
| Control, Posterolateral Fusion |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Community sample
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485289
Locations
| United States, North Carolina | |
| Triangle Orthopedics | Recruiting |
| Durham, North Carolina, United States, 27704 | |
| Contact: Crystal Hill, RN 919-281-1870 chill@triangleortho.com | |
Sponsors and Collaborators
Rachiotek LLC
More Information
No publications provided
| Responsible Party: | Rachiotek LLC |
| ClinicalTrials.gov Identifier: | NCT01485289 History of Changes |
| Other Study ID Numbers: | MLucey |
| Study First Received: | September 29, 2011 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Spinal Stenosis Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013