A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Interventional Spine, Inc.
First received: April 23, 2009
Last updated: April 25, 2012
Last verified: April 2009
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.
Lumbar Facet Disease
Device: PERPOS™ PLS
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
Primary Outcome Measures:
- Change in Oswestry Disability Index and Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Study Start Date:
| 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.
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Are within the first two PERPOS PLS System utilization experience of the investigator
- Have severe facet degeneration, radiographic findings of severe facet joint disease, degeneration of misshapen facet(s) or structural anomalies at the target fusion level that would preclude proper placement of the BONE-LOK Implant.
- Have evidenced malingering behavior related to workman's compensation claims
- Have had any significant prior intervention (greater than an injection) in the facet joint to be treated, or within two (2) levels above or two (2) levels below the facet joint to be treated
- Have had prior instrumentation of involved vertebrae at any time
- Have osteoporotic bone at the lumbar spine level to be treated based on the SCORE (Simple Calculated Osteoporosis Risk Estimation) screening questionnaire, (or a DEXA bone density measured T score <-1.0.).
- Have scoliosis with lateral angulation >20 degrees
- Have an active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless s/he has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.
- Have a cyst in the canal associated with the facet
- Have neurologic deficit bowel or bladder dysfunction
- Have spinal canal or neural foramen compromise
- Have an infection (local or systemic)
- Have myelopathy
- Have abnormal coagulation time
- Have been or will be on anticoagulation therapy within 10 days of the study procedure
- Have radiculopathy
- Have cord compression or canal compromise requiring surgery for decompression
- Have disabling back pain secondary to another cause
- Have COPD that poses anesthesia risk
- Have severe cardiopulmonary deficiencies
- Have narcotic dependence or >90 days of narcotic pain medications
- Are morbidly obese (BMI >40)
- Have uncontrolled diabetes
- Have known allergies to implant materials, e.g., titanium.
- Are currently pregnant or lactating or considering becoming pregnant during the follow-up period
- Have been involved in an investigational drug or device study within the previous 30 days
No Contacts or Locations Provided
No publications provided
||Interventional Spine, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 23, 2009
||April 25, 2012
||United States: Institutional Review Board
Keywords provided by Interventional Spine, Inc.:
ClinicalTrials.gov processed this record on March 13, 2014