Dermabond versus suture fixation for spinal cord stimulator trial lead anchoring: a randomized within-patient controlled trial.
Robert W Hurley, Janus S Patel, Daniel J Bintrim et al.
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In 30 seconds
This prospective, randomized within-patient controlled trial compared Dermabond with suture for anchoring bilateral thoracic percutaneous spinal cord stimulator trial leads in 48 adults. Mean absolute radiographic migration was 9.15 ± 14.49 mm with Dermabond and 10.60 ± 17.42 mm with suture; the paired difference was -1.46 mm (95% CI, -6.73 to 3.81; P = .58). Dermabond was not superior, but migration was within the study’s prespecified clinically meaningful threshold for comparable stability. Male sex and prior spine surgery, rather than fixation method, were associated with greater migration.
Key findings
- Mean migration was 9.15 ± 14.49 mm with Dermabond versus 10.60 ± 17.42 mm with suture; paired difference -1.46 mm (95% CI, -6.73 to 3.81; P = .58).
- Clinically significant (≥9 mm) migration occurred in 27.1% of Dermabond and 22.9% of suture leads (McNemar P = .77).
- Male sex (+8.17 mm; P = .036) and prior spine surgery (+7.08 mm; P = .048) predicted greater migration in adjusted analyses; BMI, age, and fixation method did not.
Why it matters
Lead migration can affect the stability of spinal cord stimulator trials. This within-patient comparison suggests that Dermabond may provide stability comparable to suture, while the observed associations with sex and prior spine surgery point to patient-level factors as potentially relevant to migration. The findings help distinguish the performance of an alternative anchoring method from characteristics associated with migration.
What to keep in mind
The trial included 48 adults at a single academic medical center undergoing bilateral thoracic lead placement; the abstract does not report longer-term outcomes beyond the end of the trial.