Evidence map›Paper›PMID 40624980›Full record

Trial reportPain management2025

STIMFIX™ anchoring in percutaneous spinal cord stimulation trials: interim analysis of a multicenter study.

Maja Green, Lakshmi Narra, Saurabh Dang, Jack Diep, Dipan Patel, Philip Lim, Joseph Atallah, Krishnan Chakravarthy

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pain management, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05651646 (STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05651646 naunknown statusnot on this map

STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads (SECURE Study)

TypeinterventionalSponsorSTIMFIXRan2021 to 2023Enrolled50ConditionsPainArmsIntervention Arm (STIMFIX)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Maja GreenClinical Research Organization, Solaris Research Institute Inc, Delaware, USA.ORCID 0000-0002-7982-2503
Lakshmi NarraJersey Shore University Medical Center, Neptune, NJ, USA.ORCID 0000-0003-2058-873X
Saurabh DangGarden State Pain & Orthopedics, Clifton, NJ, USA.
Jack DiepAccufix Medical, San Diego, CA, USA.ORCID 0000-0001-5845-4898
Dipan PatelGarden State Pain & Orthopedics, Clifton, NJ, USA.ORCID 0000-0002-1381-5351
Philip LimAccufix Medical, San Diego, CA, USA.ORCID 0009-0006-4367-0946
Joseph AtallahUniversity of Toledo, Toledo, OH, USA.ORCID 0000-0001-8763-2067
Krishnan ChakravarthyClinical Research Organization, Solaris Research Institute Inc, Delaware, USA.ORCID 0000-0002-7994-3786

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsLead 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 &

methodsThis interim analysis included two prospectively collected cohorts. Group 1 (

resultsMean 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 (

conclusionsSTIMFIX 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 registrationwww.clinicaltrials.gov identifier is NCT05651646.

Indexed as

Electrodes, ImplantedForeign-Body MigrationSpinal Cord StimulationAdultAgedFemaleHumansMaleMiddle AgedProspective Studiesanchoring techniqueepidural spacelead migrationPercutaneous spinal cord stimulationtrial leads

Identifiers

PMID40624980
PMCPMC12320872

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.