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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.
Complications associated with Teflon implants in the treatment of Trigeminal Neuralgia 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. At the reporting institution, the investigators have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, positioned at a distance from the trigeminal nerve itself. The goal of this technique is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To date, no published studies have directly correlated the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. The present study seeks to address this gap by retrospectively analyzing the outcomes of microvascular decompression 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microvascular decompression for trigeminal neuralgia | Procedure | Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Trigeminal Neuralgia treated with microvascular decompression
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Moratal, Secretary | Fundación Consorcio Hospital General Universitario de Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorcio Hospital General Universitario de Valencia | Valencia | Valencia | 46015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18077952 | Result | 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. | |
| 31786660 |
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Once the study is finised we will decide what to do
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D061145 | Microvascular Decompression Surgery |
| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
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| 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. |
| 20419329 | 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. |
| 27320780 | 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. |
| 36570809 | 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. |
| 18981841 | 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. |
| 33134025 | 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. |
| 3363593 | 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. |
| 39794712 | 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. |
| 34049739 | 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. |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |