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STIMFIX™ anchoring in percutaneous spinal cord stimulation trials: interim analysis of a multicenter study
Maja Green1, Lakshmi Narra2, Saurabh Dang3,4
1Clinical Research Organization, Solaris Research Institute Inc, Delaware, USA.
Aims:
Lead migration during percutaneous spinal cord stimulation (SCS) trials can undermine therapeutic efficacy. This study evaluates the effectiveness of the novel, noninvasive STIMFIX anchoring system in reducing lead migration compared to conventional anchoring techniques.
Patients & Methods:
This interim analysis included two prospectively collected cohorts. Group 1 (n = 28) was a randomized, single-center trial comparing three anchoring methods: sutures (n = 9), adhesive tape (n = 10), and manufacturer-provided anchors (n = 9). Group 2 (n = 20) was a multicenter, open-label, non-randomized study using STIMFIX anchors. Lead migration was measured via standardized fluoroscopic imaging on Days 1 and 7.
Results:
Mean lead migration in Group 1 was 33.5 mm (manufacturer anchor), 29.4 mm (tape), and 21.1 mm (sutures), with no significant differences between groups (p = 0.404). Group 2 demonstrated an average lead migration of 19.5 mm with STIMFIX. No major adverse events were reported; one case of minor skin irritation resolved without intervention.
Conclusions:
STIMFIX demonstrated reduced lead migration compared to conventional methods, with favorable safety and ease of application. These findings support its use as a promising advancement in SCS trial anchoring.
Clinical Trial Registration:
www.clinicaltrials.gov identifier is NCT05651646.
