Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor
NCT ID: NCT01126983
Last Updated: 2010-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2010-05-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
NCT05914311
Study to Evaluate Safety and Effectiveness of Spinal Sealant
NCT00594035
Use of Spinal Sealant System During Spinal Surgery
NCT00458354
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
NCT04563806
Cervical Interbody Implant Study
NCT04689854
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-Suture
No suture will be used to secure the leads. Benzoin and Steri-Strips will be used like in the other two arms.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.
18 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Spine Care, Oklahoma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Spine Care of Oklahoma
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward Shadid, M.D
Role: PRINCIPAL_INVESTIGATOR
Spine Care of Oklahoma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spine Care of Oklahoma
Oklahoma City, Oklahoma, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254.
Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M. Spinal cord stimulation for chronic reflex sympathetic dystrophy--five-year follow-up. N Engl J Med. 2006 Jun 1;354(22):2394-6. doi: 10.1056/NEJMc055504. No abstract available.
Brook AL, Georgy BA, Olan WJ. Spinal cord stimulation: a basic approach. Tech Vasc Interv Radiol. 2009 Mar;12(1):64-70. doi: 10.1053/j.tvir.2009.06.007.
Holsheimer J, Barolat G, Struijk JJ, He J. Significance of the spinal cord position in spinal cord stimulation. Acta Neurochir Suppl. 1995;64:119-24. doi: 10.1007/978-3-7091-9419-5_26.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J. 2001 Sep-Oct;1(5):358-63. doi: 10.1016/s1529-9430(01)00083-3.
Jang HD, Kim MS, Chang CH, Kim SW, Kim OL, Kim SH. Analysis of failed spinal cord stimulation trials in the treatment of intractable chronic pain. J Korean Neurosurg Soc. 2008 Feb;43(2):85-9. doi: 10.3340/jkns.2008.43.2.85. Epub 2008 Feb 20.
Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM. Failure modes of spinal cord stimulation hardware. J Neurosurg Spine. 2006 Sep;5(3):183-90. doi: 10.3171/spi.2006.5.3.183.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine. 2006 Sep;5(3):191-203. doi: 10.3171/spi.2006.5.3.191.
Park CH, Huh B. Lodged spinal cord stimulator trial lead: a case report. Pain Pract. 2008 May-Jun;8(3):210-3. doi: 10.1111/j.1533-2500.2008.00199.x.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
spinecareleads
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.