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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485289
• Other study ID #: MLucey
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: October 3, 2016
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2016
• Source: Rachiotek LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 This applies only if the patient was formally withdrawn from the study at that time.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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Stenosis

Locations

Country	Name	City	State
United States	Triangle Orthopedics	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Rachiotek LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Major Device Related (MDR) Complications	Patient experiences no major device-related complications	Minimum 24 months post procedure	Yes
Primary	Revision, Reoperation, or Removal	The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.	Minimum 24 months post procedure	Yes
Secondary	Oswestry Disability Index (ODI)	Changes from baseline in function scores (Oswestry Disability Index)	Minimum 24 months post procedure	No
Secondary	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	No
Secondary	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	Yes
Secondary	Physician Satisfaction Scale	Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.	Immediately post procedure	No