Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency neurotomy subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Procedures in Which Temperature of Screws Increased | 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. | 2 hours |
Not provided
Not provided
Inclusion Criteria:
- Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous spinal surgery
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tim J Lamer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25580992 | Background | Gazelka HM, Welch TL, Nassr A, Lamer TJ. Safety of lumbar spine radiofrequency procedures in the presence of posterior pedicle screws: technical report of a cadaver study. Pain Med. 2015 May;16(5):877-80. doi: 10.1111/pme.12678. Epub 2015 Jan 8. | |
| 26764338 | Result | Lamer TJ, Smith J, Hoelzer BC, Mauck WD, Qu W, Gazelka HM. Safety of Lumbar Spine Radiofrequency Procedures in Patients Who Have Posterior Spinal Hardware. Pain Med. 2016 Sep;17(9):1634-7. doi: 10.1093/pm/pnv078. Epub 2016 Jan 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Neurotomy Subjects | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Neurotomy Subjects | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Procedures in Which Temperature of Screws Increased | 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. | There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed. | Posted | Number | procedures | 2 hours | Procedures | Procedures |
|
Adverse events were collect during the procedure.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Neurotomy Subjects | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tim J. Lamer, M.D. | Mayo Clinic | 507 778-8760 | lamer.tim@mayo.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Procedures |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
Not provided
Not provided
Not provided