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

NCT01485289 | Completed

• 1 other identifier: MLucey
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Oswestry Disability Index (ODI)

  Minimum 24 months post procedure

• Presence (control) or Absence (Stabilimax)of fusion

  Minimum 24 months post procedure

• Adverse Events (AE)

  Minimum 24 months post procedure

• Physician Satisfaction Scale

  Immediately post procedure

Study Arms (2)

Investigational Stabilimax

Control, Posterolateral Fusion

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rachiotek LLC: lead

Study Sites (1)

Triangle Orthopedics

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: December 5, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

US (1)