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OpenTrials
Completed

NCT Number: NCT02210052

Safety of Spine Radiofrequency Procedures

The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN) of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion, would lead to an increase in the temperature of the pedicle screws.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

About this study

This study was a prospective clinical trial, examining outcomes related to temperature increases in pedicle screws. It was not possible to blind the investigators or the patient. Outcomes related temperature differences were collected at each pedicle screw adjacent to a zygapophyseal joint being treated.

A conventional 18-gauge, 1-cm curved active tip radiofrequency cannula was placed under fluoroscopic guidance to the area to be treated (the junction of the transverse process and the superior articulating process of the facet joint). This position placed the tip of the radiofrequency cannula immediately adjacent to, but not in direct contact with, the pedicle screws. The radiofrequency cannula was connected to a radiofrequency generator, and the conventional settings for clinical medial branch neurotomy was used, heating the tissue to 80°C for 90 seconds. The procedure described up to this point is the normal procedure and protocol for RFN performed at the Mayo Clinic.

The experimental portion of the procedure is as follows: A separate 22 gauge radiofrequency cannula was intentionally placed in direct contact with the dorsal surface of the pedicle screws and was connected to a radiofrequency generator solely for the purpose of measuring temperature, as the RF cannula are dual purpose probes capable of both conducting energy for the radiofrequency lesion and monitoring tissue temperature. In other words, this small gauge needle was placed for the sole purpose of acting as a thermistor probe/temperature monitor. This process was repeated for each level necessary for treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous spinal surgery

Exclusion criteria

  • Active infection over skin where needle will be placed
  • Coagulopathy
  • Pregnancy

Treatment and study plan

Radiofrequency cannula

Device

Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.

Primary outcomes

  1. Number of Procedures in Which Temperature of Screws Increased

    Time frame: 2 hours

    The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Safety of Lumbar Spine Radiofrequency Procedures in the Presence of Posterior Pedicle Screws: A Prospective Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.