Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor
To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period.
Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor Securing Methods: A Randomized Single Blind Clinical Trial for Better Outcomes.|
- Migration of leads with different methods of securing leads during spinal cord stimulation trial period. [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms.
Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.
Other Name: 2.0 Mono-filament nylon sutureDevice: Lead Anchor
Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.
Other Name: 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106
Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin.
Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are
- suturing the leads using 2.0 mono-filament nylon to the skin,
- suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,
- non- suture.
In all three groups copious amounts of benzoin and steri-strips will be used.
Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126983
|United States, Oklahoma|
|Spine Care of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73112|
|Principal Investigator:||Edward Shadid, M.D||Spine Care of Oklahoma|