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

University of Valencia

Status: Completed

Conditions: Microvascular Decompression; Trigeminal Neuralgia; Teflon

Treatments: Procedure: Microvascular decompression for trigeminal neuralgia

Study type: Observational

Funder types: Other

Identifiers

NCT07046247

188/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Teflon pledgets group

Description:

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.

Treatment:

Procedure: Microvascular decompression for trigeminal neuralgia

Shredded Teflon group

Description:

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.

Treatment:

Procedure: Microvascular decompression for trigeminal neuralgia