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Completed

NCT Number: NCT01126983

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.

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Key information

Conditions

Spinal Cord Stimulation

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Care of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suture

Device

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 names: 2.0 Mono-filament nylon suture

Lead Anchor

Device

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 names: 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106

Primary outcomes

  1. Migration of leads with different methods of securing leads during spinal cord stimulation trial period.

    Time frame: 3-5 days

Sponsors and collaborators

Lead sponsor

Spine Care, Oklahoma

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 20, 2010
Registry last updated
Jul 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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