Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Rachiotek LLC.
Recruitment status was  Recruiting
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014