Radiofrequency Ablation in Patients With Spinal HardwareNCT02210052
Safety of Spine Radiofrequency Procedures
A study testing Radiofrequency cannula in people with Radiofrequency Ablation in Patients With Spinal Hardware, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiofrequency Ablation in Patients With Spinal Hardware
- What is being tested?
- Radiofrequency cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous spinal surgery
Who cannot join
- Active infection over skin where needle will be placed
- Coagulopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Lumbar Spine Radiofrequency Procedures in the Presence of Posterior Pedicle Screws: A Prospective Trial
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.
Read the detailed description
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.
- Being tested
- Radiofrequency cannula
- Keywords
- radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency cannulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Radiofrequency cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiofrequency Ablation in Patients With Spinal HardwareStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim J. Lamer, M.D., Mayo Clinic
- Investigators
- Tim J Lamer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210052
- Sponsor's protocol ID
- 14-003619
- Status last verified
- Jun 2017
- First submitted
- 4 Aug 2014
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25580992Lamer 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.
PubMed 26764338
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Lumbar Spine Radiofrequency Procedures in the Presence of Posterior Pedicle Screws: A Prospective Trial
- ClinicalTrials.gov ID
- NCT02210052
- Acronym / sponsor ID
- 14-003619
- Keywords
- radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency neurotomy subjects | Experimental | Device: Radiofrequency cannulaSubjects 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous spinal surgery
Key exclusion criteria (3 listed)
- Active infection over skin where needle will be placed
- Coagulopathy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency cannulaSubjects 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. | Device | Radiofrequency neurotomy subjects |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25580992Gazelka 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.
- Results publication: PubMed 26764338Lamer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim J Lamer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency cannula in people with Radiofrequency Ablation in Patients With Spinal Hardware, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Procedures in Which Temperature of Screws Increased (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210052, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.