Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
125 participants
OBSERVATIONAL
2012-11-30
2013-06-30
Brief Summary
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Detailed Description
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* Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
* Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
* Change in Oswestry Disability Index (ODI) score from baseline
* Proportion of patients with a device related complication
* Proportion of patients with lack of revision, removal, or reoperation
* Proportion of patients with radiographic fusion
Conditions
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Study Design
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CASE_ONLY
Study Groups
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PerX360º System™
Patients treated with PerX360º System™
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
* Age \> 18 years
* Patient is treated with the Optiport™ and Opticage™ products
18 Years
ALL
No
Sponsors
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Interventional Spine, Inc.
INDUSTRY
Responsible Party
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Locations
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Los Angeles Brain and Spine Institute
Los Angeles, California, United States
Flagler Hospital
Saint Augustine, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TP201
Identifier Type: -
Identifier Source: org_study_id
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