Status:
COMPLETED
Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression
Lead Sponsor:
ArthroCare Corporation
Conditions:
Radicular Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The goal of this post-marketing surveillance study is to compare two procedures which are used to treat patients who require a disc decompression procedure. These procedures are: 1) plasma disc decomp...
Detailed Description
Chronic leg and back pain are two of the most common ailments in our society, and are associated with serious financial and social consequences. One surgical treatment modality is plasma disc decompre...
Eligibility Criteria
Inclusion
- Patient has one symptomatic contained, focal herniated lumbar disc.
- Patient's age should be at least 18 years old and no more than 75 years old.
- Selective nerve root injection or epidural steroid injection for symptomatic herniated disc, received between 3 weeks and six months ago.
- A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
- Radicular pain concordant with image findings (MRI or CT).
- Disc height greater than 50%.
- Patient signs informed consent.
Exclusion
- Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
- Patient is receiving Worker's compensation or is in litigation related to back/leg pain.
- Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
- Allergy to contrast media or drugs to be used in the intended procedure.
- Medical co-morbidities that preclude surgical intervention.
- Patient is receiving anti-psychotic therapy.
- Patient is a prisoner.
- Patient is incapable of understanding or responding to the study questionnaires.
- History of previous spinal surgery at, or directly adjacent to, the level to be treated.
- Patient is morbidly obese (BMI ≥ 40).
- Patient is simultaneously participating in another device or drug study related to limb/axial pain.
- Patient has a spinal fracture, tumor or infection.
- Radicular pain originating from more than one disc level.
- Axial (back) pain greater than radicular (leg) pain.
- Clinical evidence of cauda equina syndrome.
- Progressive neurologic deficit.
- Radiological evidence of spondylolisthesis at the level to be treated.
- Radiological evidence of moderate/severe stenosis at the level to be treated.
- Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00189605
Start Date
September 1 2004
End Date
April 1 2009
Last Update
August 26 2015
Active Locations (13)
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1
The Orthopedic Clinic Association
Scottsdale, Arizona, United States, 85260
2
Innovative Spine Care
Little Rock, Arkansas, United States, 72205
3
SpectrumCare Rehabilitation Medical Center Inc.
Napa, California, United States, 94558
4
North Valley Rehabilitation Hospital
Thornton, Colorado, United States, 80229