Impact of Teflon Implantation Technique on Nervous Tissue and Recurrence Rates Following Microvascular Decompression for Trigeminal Neuralgia

NCT ID: NCT07046247

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-12

Brief Summary

The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form.

Detailed Description

Complications associated with Teflon implants in the treatment of Trigeminal Neuraglia have been reported, including granuloma formation and persistent neuroinflammation, which can mimic tumor recurrence or lead to renewed symptoms. These concerns underscore the importance of precise implant positioning and accurate volume control. In our institution, we have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, far from the trigeminal nerve itself. The goal is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To our knowledge, to date, there are no published studies directly correlating the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. Our study aims to fill this gap by retrospectively analyzing the outcomes of MVD procedures performed using this specific Teflon application method, correlating clinical outcomes with MRI findings to assess the degree of inflammatory response and the likelihood of symptom recurrence.

Conditions

Trigeminal Neuralgia; Microvascular Decompression; Teflon

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Teflon pledgets group

Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be Teflon, placed in the form of one or more pledgets between the nerve and the vessel.

Microvascular decompression for trigeminal neuralgia

Intervention Type: PROCEDURE

Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant

Shredded Teflon group

Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be shredded Teflon, placed around the displaced vessel away from the trigeminal nerve, aiming to induce a localized arachnoiditis away from the nerve that will fix the vessel in its new position, without any contact between the nerve and the vessel or the Teflon implant.

Microvascular decompression for trigeminal neuralgia

Intervention Type: PROCEDURE

Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant

Interventions

Microvascular decompression for trigeminal neuralgia

Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Trigeminal Neuralgia refractory to medical therapy and treated via microvascular decompression

Exclusion Criteria

• Other craniofacial neuralgias, atypical facial pain, trigeminal neuralgia (TN) due to non-vascular causes (e.g., multiple sclerosis), and those with posterior fossa pathology, such as tumors, infarctions, hematomas, infections, or inflammatory lesions
• Patients treated by alternative methods, including percutaneous radiofrequency thermocoagulation, glycerol injection, balloon compression, or radiosurgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Vicente Vanaclocha

University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Moratal, Secretary

Role: STUDY_DIRECTOR

Fundación Consorcio Hospital General Universitario de Valencia

Locations

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Countries

Spain

References

Sindou M, Leston J, Decullier E, Chapuis F. Microvascular decompression for primary trigeminal neuralgia: long-term effectiveness and prognostic factors in a series of 362 consecutive patients with clear-cut neurovascular conflicts who underwent pure decompression. J Neurosurg. 2007 Dec;107(6):1144-53. doi: 10.3171/JNS-07/12/1144.

Reference Type: BACKGROUND

PMID: 18077952 (View on PubMed)

Pressman E, Jha RT, Zavadskiy G, Kumar JI, van Loveren H, van Gompel JJ, Agazzi S. Teflon or Ivalon(R): a scoping review of implants used in microvascular decompression for trigeminal neuralgia. Neurosurg Rev. 2020 Feb;43(1):79-86. doi: 10.1007/s10143-019-01187-0. Epub 2019 Nov 30.

Reference Type: BACKGROUND

PMID: 31786660 (View on PubMed)

Capelle HH, Brandis A, Tschan CA, Krauss JK. Treatment of recurrent trigeminal neuralgia due to Teflon granuloma. J Headache Pain. 2010 Aug;11(4):339-44. doi: 10.1007/s10194-010-0213-4. Epub 2010 Apr 24.

Reference Type: BACKGROUND

PMID: 20419329 (View on PubMed)

Deep NL, Graffeo CS, Copeland WR 3rd, Link MJ, Atkinson JL, Neff BA, Raghunathan A, Carlson ML. Teflon granulomas mimicking cerebellopontine angle tumors following microvascular decompression. Laryngoscope. 2017 Mar;127(3):715-719. doi: 10.1002/lary.26126. Epub 2016 Jun 19.

Reference Type: BACKGROUND

PMID: 27320780 (View on PubMed)

Prasetya M, Adidharma P, Inoue T, Sulistyanto A, Fadhil, Oswari S, Keswani RR, Kusdiansah M, Aji YK, Arham A. Case report: Teflon granuloma following microvascular decompression manifesting as light-triggered trigeminal neuralgia. Front Surg. 2022 Jul 22;9:904434. doi: 10.3389/fsurg.2022.904434. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36570809 (View on PubMed)

Sindou M, Leston JM, Decullier E, Chapuis F. Microvascular decompression for trigeminal neuralgia: the importance of a noncompressive technique--Kaplan-Meier analysis in a consecutive series of 330 patients. Neurosurgery. 2008 Oct;63(4 Suppl 2):341-50; discussion 350-1. doi: 10.1227/01.NEU.0000327022.79171.D6.

Reference Type: BACKGROUND

PMID: 18981841 (View on PubMed)

Zheng JH, Sun K, Zhang HT, Xie YJ, Wang-Yang LX, Chen HY, Wang C. A Study on the Recurrence Rate of Trigeminal Neuralgia after MVD and the Related Factors. J Neurol Surg B Skull Base. 2020 Oct;81(5):572-578. doi: 10.1055/s-0039-1692687. Epub 2019 Jul 24.

Reference Type: BACKGROUND

PMID: 33134025 (View on PubMed)

van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.

Reference Type: BACKGROUND

PMID: 3363593 (View on PubMed)

Okon II, Menon SS, Osama M, Aiman M, Paleare LFF, Eliseo DL 3rd, Shafqat MD, Ezeaku CO, Ferreira MY, Razouqi Y, Kapsetaki M, Saniel JDR, Panit NM, Rao AG, Iqbal U, Otobo DD, Alkhawaldeh IM, Pereira FS, Akbar I, Kasimieh O, Chaurasia B. Microvascular decompression: a contemporary update. BMC Surg. 2025 Jan 11;25(1):20. doi: 10.1186/s12893-025-02762-7.

Reference Type: BACKGROUND

PMID: 39794712 (View on PubMed)

Amaya Pascasio L, De La Casa-Fages B, Esteban de Antonio E, Grandas F, Garcia-Leal R, Ruiz Juretschke F. Microvascular decompression for trigeminal neuralgia: A retrospective analysis of long-term outcomes and prognostic factors. Neurologia (Engl Ed). 2021 May 25:S0213-4853(21)00071-2. doi: 10.1016/j.nrl.2021.03.009. Online ahead of print. English, Spanish.

Reference Type: BACKGROUND

PMID: 34049739 (View on PubMed)

Other Identifiers

188/2020

Identifier Type: -

Identifier Source: org_study_id