Impact of Teflon Technique on Recurrence After Microvascular Decompression for Trigeminal Neuralgia

NCT07046247 | Completed DMC

• 1 other identifier: 188/2020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia; Microvascular Decompression; Teflon

Keywords

Trigeminal Neuralgia; Microvascular Decompression; Teflon Implant; Neurosurgical Techniques; Postoperative Complications; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Modified Ranking scale

  The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)

  5 years

• Barrow Neurological Institute Pain Intensity Scale

  The Barrow Neurological Institute (BNI) Pain Intensity Scale will be used to assess pain control, ranging from 1 (no pain, no medication) to 5 (severe pain without relief)

  5 years

Study Arms (2)

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.

Procedure: Microvascular decompression for trigeminal neuralgia

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.

Procedure: Microvascular decompression for trigeminal neuralgia

Interventions

Microvascular decompression for trigeminal neuralgia PROCEDURE

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

Shredded Teflon group; Teflon pledgets group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Trigeminal Neuralgia treated with microvascular decompression

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

Location

Related Publications (10)

• 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.

  PMID: 18077952 RESULT

• 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.

  PMID: 31786660 RESULT

• 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.

  PMID: 20419329 RESULT

• 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.

  PMID: 27320780 RESULT

• 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.

  PMID: 36570809 RESULT

• 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.

  PMID: 18981841 RESULT

• 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.

  PMID: 33134025 RESULT

• 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.

  PMID: 3363593 RESULT

• 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.

  PMID: 39794712 RESULT

• 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.

  PMID: 34049739 RESULT

MeSH Terms

Conditions

Trigeminal Neuralgia; Postoperative Complications

Interventions

Microvascular Decompression Surgery

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Teresa Moratal, Secretary

  Fundación Consorcio Hospital General Universitario de Valencia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 12, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-06

Locations

ES (1)