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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01485289

Enrollment

Registered

2011-12-05

Start date

2011-08-31

Completion date

2012-12-31

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Revision, Reoperation, or Removal	Minimum 24 months post procedure	The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
Visual Analog Scale (VAS) for Leg Pain	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)
Zurich Claudication Questionnaire (ZCQ)	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
Major Device Related (MDR) Complications	Minimum 24 months post procedure	Patient experiences no major device-related complications

Secondary

Measure	Time frame	Description
Oswestry Disability Index (ODI)	Minimum 24 months post procedure	Changes from baseline in function scores (Oswestry Disability Index)
Presence (control) or Absence (Stabilimax)of fusion	Minimum 24 months post procedure	Presence (control patients) or absence (Stabilimax NZ® patients) of fusion at 24-months post procedure
Adverse Events (AE)	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.
Physician Satisfaction Scale	Immediately post procedure	Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.

Countries

United States

Outcome results