A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System|
- Change in Oswestry Disability Index and Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: PERPOS™ PLS
Minimally invasive transfacet fixation with PERPOS™ PLS as an aid to fusion
Device: PERPOS™ PLS
To stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.
The PERPOS™ PLS System involves a minimally invasive, percutaneous implant procedure via a small incision.
The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
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