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

Completed

• Conditions: Trigeminal Neuralgia; Microvascular Decompression; Teflon

• Registration Number: NCT07046247
• Lead Sponsor: University of Valencia

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.

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-12
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Ranking scale	5 years	The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)
Barrow Neurological Institute Pain Intensity Scale	5 years	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)

Trial Locations

Locations (1)

Consorcio Hospital General Universitario de Valencia; 🇪🇸 València, Valencia, Spain