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

July 7, 2010 updated by: Spine Care, Oklahoma

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Spine Care of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Suture
No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms.
Device: Suture
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
Device: 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 Names:
  • 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migration of leads with different methods of securing leads during spinal cord stimulation trial period.
Time Frame: 3-5 days
3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spine Care, Oklahoma

Investigators

  • Principal Investigator: Edward Shadid, M.D, Spine Care of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 16, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • spinecareleads

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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