Evidence map›Paper›PMID 28083804›Full record

ArticleInternational journal of computer assisted radiology and surgery2017

Improved surgical procedure using intraoperative navigation for the implantation of the SPG microstimulator in patients with chronic cluster headache.

Carsten Kohlmeier, Peter Behrens, Andreas Böger, Brinda Ramachandran, Anthony Caparso, Dirk Schulze, Philipp Stude, Max Heiland, Alexandre T Assaf

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in International journal of computer assisted radiology and surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03567590 (A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
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.

NCT03567590 nacompletednot on this mapstarted 2018, after this paper: background citation

A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

TypeinterventionalSponsorBeijing Tiantan HospitalRan2018 to 2021Enrolled80ConditionsCluster HeadacheArmsPulsed Radiofrequency treatment, Nerve Block treatment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

9 authors at 4 institutions in 1 country.

Carsten KohlmeierDepartment of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, University of Hamburg, Martinistr. 52, 20246, Hamburg, Germany.
Peter BehrensInterdisciplinary Pain Center, University Hospital Freiburg, University of Freiburg, Breisacherstraße 64, 79106, Freiburg, Germany.
Andreas BögerDepartment of Neurology, Pain Clinic, Red Cross Hospital Kassel, Hansteinstrasse 29, 34121, Kassel, Germany.
Brinda RamachandranAutonomic Technologies, Inc., Redwood City, CA, USA.
Anthony CaparsoAutonomic Technologies, Inc., Redwood City, CA, USA.
Dirk SchulzeDigitales Diagnostikzentrum Breisgau, Kaiser-Joseph-Straße 263, 79098, Freiburg, Germany.
Philipp StudeDepartment of Neurology, University Hospital Bergmannsheil, University of Bochum, Buerkle-de-la-Camp Platz 1, 44789, Bochum, Germany.
Max HeilandDepartment of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, University of Hamburg, Martinistr. 52, 20246, Hamburg, Germany.
Alexandre T AssafDepartment of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, University of Hamburg, Martinistr. 52, 20246, Hamburg, Germany. a.assaf@uke.uni-hamburg.de.
Universität Hamburg · DEBG University Hospital Bergmannsheil Bochum · DEUniversity Medical Center Hamburg-Eppendorf · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe ATI SPG microstimulator is designed to be fixed on the posterior maxilla, with the integrated lead extending into the pterygopalatine fossa to electrically stimulate the sphenopalatine ganglion (SPG) as a treatment for cluster headache. Preoperative surgical planning to ensure the placement of the microstimulator in close proximity (within 5 mm) to the SPG is critical for treatment efficacy. The aim of this study was to improve the surgical procedure by navigating the initial dissection prior to implantation using a passive optical navigation system and to match the post-operative CBCT images with the preoperative treatment plan to verify the accuracy of the intraoperative placement of the microstimulator.

methodsCustom methods and software were used that result in a 3D rotatable digitally reconstructed fluoroscopic image illustrating the patient-specific placement with the ATI SPG microstimulator. Those software tools were preoperatively integrated with the planning software of the navigation system to be used intraoperatively for navigated placement. Intraoperatively, the SPG microstimulator was implanted by completing the initial dissection with CT navigation, while the final position of the stimulator was verified by 3D CBCT. Those reconstructed images were then immediately matched with the preoperative CT scans with the digitally inserted SPG microstimulator. This method allowed for visual comparison of both CT scans and verified correct positioning of the SPG microstimulator.

resultsTwenty-four surgeries were performed using this new method of CT navigated assistance during SPG microstimulator implantation. Those results were compared to results of 21 patients previously implanted without the assistance of CT navigation. Using CT navigation during the initial dissection, an average distance reduction of 1.2 mm between the target point and electrode tip of the SPG microstimulator was achieved. Using the navigation software for navigated implantation and matching the preoperative planned scans with those performed post-operatively, the average distance was 2.17 mm with navigation, compared to 3.37 mm in the 28 surgeries without navigation.

conclusionResults from this new procedure showed a significant reduction (p = 0.009) in the average distance from the SPG microstimulator to the desired target point. Therefore, a distinct improvement could be achieved in positioning of the SPG microstimulator through the use of intraoperative navigation during the initial dissection and by post-operative matching of pre- and post-operatively performed CBCT scans.

Indexed as

Electrodes, ImplantedAdultChronic DiseaseCluster HeadacheElectric Stimulation TherapyFemaleGanglia, ParasympatheticHumansImage Processing, Computer-AssistedIntraoperative PeriodMaleSurgery, Computer-AssistedTomography, X-Ray ComputedTreatment OutcomeCluster headache (CH)Cone beam computed tomography (CBCT)MicrostimulatorNavigated surgeryPterygopalatine fossa (PPF)Sphenopalatine ganglion (SPG)

Identifiers

PMID28083804
OpenAlexW2577665860

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.