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

This study has been completed.
Sponsor:
Information provided by:
Spine Care, Oklahoma
ClinicalTrials.gov Identifier:
NCT01126983
First received: May 16, 2010
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Spinal Cord Stimulation
Device: Suture
Device: Lead Anchor

Study Type: Interventional
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.

Further study details as provided by Spine Care, Oklahoma:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126983

Locations
United States, Oklahoma
Spine Care of Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Spine Care, Oklahoma
Investigators
Principal Investigator: Edward Shadid, M.D Spine Care of Oklahoma
  More Information

Additional Information:
Publications:
Responsible Party: Spine Care of Oklahoma
ClinicalTrials.gov Identifier: NCT01126983     History of Changes
Other Study ID Numbers: spinecareleads
Study First Received: May 16, 2010
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014