Dermabond Versus Suture Fixation for Spinal Cord Stimulator Trial Lead Anchoring: A Randomized Within-Patient Controlled Trial.

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.