A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00887835|
Recruitment Status : Withdrawn
First Posted : April 24, 2009
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Facet Disease||Device: PERPOS™ PLS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||October 2010|
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.
- Change in Oswestry Disability Index and Visual Analogue Scale [ Time Frame: 1 year ]