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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Triangle Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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 This applies only if the patient was formally withdrawn from the study at that time.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Investigational Stabilimax
Control, Posterolateral Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rachiotek LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: MLucey