NCT00189605

Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression

Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: ArthroCare Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 decompression procedure using Coblation technology and 2) fluoroscopy guided transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy and rate of improvement in symptoms through the first six months following the procedure. The principal objectives of this study are to determine whether subjects receiving the plasma disc decompression procedure demonstrate: 1. Improved clinical outcomes over subjects receiving TFESI 2. More rapid reversal of symptoms than subjects receiving TFESI

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 decompression, based on the principle that inducing a small reduction of volume in the closed hydraulic space of an intact (contained herniated) disc can relieve pressure, and thereby reduce or eliminate pain. Another widely accepted treatment is transforaminal epidural steroid injection (TFESI), which delivers a high concentration of corticosteroid to the targeted disc nerve interface, and is thought to decrease pain by reducing inflammation. This study proposes to compare the efficacy of the plasma disc decompression procedure to the standard TFESI series in patients who have failed to improve after an initial TFESI injection. The goal is to better understand the differences between these two treatment modalities and to monitor the rates of symptom improvement through the first six months between patients receiving a series of at least two selective nerve root injections and those undergoing the one-time plasma disc decompression procedure after failing one fluoroscopy guided TFESI. Patients will continue to be monitored over the 2-year post-procedure period to assess stability of treatment effect.

Conditions

• Radicular Pain

Interventions

Type	Name	Description
DEVICE	Perc-DLR/Perc-DLG	Device technique will be used per IFU
DRUG	Fluoroscopy guided transforaminal epidural steroid injection (TFESI)	Injection of steroid solution into the lumbar level

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-12-01
• Completion: 2009-04-01
• First posted: 2005-09-19
• Last updated: 2015-08-26

Locations

13 sites across 1 country: United States