Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor

Spine Care, Oklahoma

Status: Completed

Conditions: Spinal Cord Stimulation

Treatments: Device: Lead Anchor; Device: Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT01126983

spinecareleads

Details and patient eligibility

About

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.

Full description

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

1. suturing the leads using 2.0 mono-filament nylon to the skin,
2. suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,
3. 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All the patients undergoing Spinal Cord Stimulation (age > 18yrs)

Exclusion criteria

• patients whose trial period lasts less than 3 days or more than 5 days will be excluded from the study.
• patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 1 patient group

Non-Suture

Experimental group

Description:

No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms.

Treatment:

Device: Suture

Device: Lead Anchor