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Completed

NCT Number: NCT01485289

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

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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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Triangle Orthopedics

Durham, North Carolina, 27704, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 This applies only if the patient was formally withdrawn from the study at that time.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rachiotek LLC

Industry

Registry information

Official study title

Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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