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

Effect of Teflon Implant on Nerve Tissue and Its Relationship With Recurrences in the Treatment of Trigeminal Neuralgia by Microvascular Decompression, With Special Attention to the Method of Application: A Retrospective Clinical Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07046247
Enrollment
150
Registered
2025-07-01
Start date
2025-01-01
Completion date
2025-06-12
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular Decompression, Teflon, Trigeminal Neuralgia

Keywords

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

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 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.

Interventions

PROCEDUREMicrovascular decompression for trigeminal neuralgia

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

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Ranking scale5 yearsThe Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)
Barrow Neurological Institute Pain Intensity Scale5 yearsThe 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)

Countries

Spain

Contacts

STUDY_DIRECTORTeresa Moratal, Secretary

Fundación Consorcio Hospital General Universitario de Valencia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026