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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Spinal Stenosis

Study Design

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
Study Start Date : August 2011
Primary Completion Date : November 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Investigational Stabilimax
Control, Posterolateral Fusion


Outcome Measures

Primary Outcome Measures :
  1. 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)

  2. 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

  3. Major Device Related (MDR) Complications [ Time Frame: Minimum 24 months post procedure ]
    Patient experiences no major device-related complications

  4. 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 :
  1. Oswestry Disability Index (ODI) [ Time Frame: Minimum 24 months post procedure ]
    Changes from baseline in function scores (Oswestry Disability Index)

  2. 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

  3. 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.

  4. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Triangle Orthopedics
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Rachiotek LLC
More Information

Responsible Party: Rachiotek LLC
ClinicalTrials.gov Identifier: NCT01485289     History of Changes
Other Study ID Numbers: MLucey
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases