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Published on: June 26, 2018
Dermabond Versus Suture Fixation for Spinal Cord Stimulator Trial Lead Anchoring: A Randomized Within-Patient
Robert W Hurley1,2,3,4, Janus S Patel1,4, Daniel J Bintrim1,4
1Department of Anesthesiology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, United States.
Objective:
To determine whether Dermabond (2-octyl cyanoacrylate) provides superior lead stability to suture for percutaneous spinal cord stimulator (SCS) trial leads, and whether migration reflects patient-level factors rather than anchoring method.
Design:
Prospective, randomized, within-patient controlled trial (ClinicalTrials.gov NCT05914311).
Setting:
Interventional Pain and Spine Medicine Center at an academic medical center.
Subjects:
Forty-eight adults (96 leads) undergoing bilateral thoracic percutaneous SCS trial implantation.
Methods:
Within each patient, one lead was randomized to Dermabond and the contralateral lead to suture. The primary outcome was absolute radiographic lead migration (mm) between placement and end-of-trial, both imaged upright. All analyses accounted for within-patient correlation; a post hoc non-inferiority framing used the a priori 9 mm clinically meaningful threshold.
Results:
Mean absolute migration was 9.15 ± 14.49 mm (Dermabond) and 10.60 ± 17.42 mm (suture); the paired difference was -1.46 mm (95% CI, -6.73 to 3.81; p = 0.58), with the upper bound well below the 9 mm threshold. In adjusted analyses, male sex (+8.17 mm; p = 0.036) and prior spine surgery (+7.08 mm; p = 0.048) predicted greater migration; BMI, age, and fixation method did not. Clinically significant (≥9 mm) migration occurred in 27.1% of Dermabond and 22.9% of suture leads (McNemar p = 0.77).
Conclusions:
Dermabond was not superior to suture but showed clinically comparable stability, supporting it as a noninvasive alternative. The stronger signal was at the patient level: Male sex and prior spine surgery, but not BMI, predicted migration. Future efforts to reduce migration should target patient-level drivers rather than anchor choice.
