Trial Outcomes & Findings for Safety of Spine Radiofrequency Procedures (NCT NCT02210052)
NCT ID: NCT02210052
Last Updated: 2017-07-26
Results Overview
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.
COMPLETED
NA
6 participants
2 hours
2017-07-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Spine Radiofrequency Procedures
Baseline characteristics by cohort
| Measure |
Radiofrequency Neurotomy Subjects
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
47.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.
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.
Outcome measures
| Measure |
Radiofrequency Neurotomy Subjects
n=10 Procedures
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.
|
|---|---|
|
Number of Procedures in Which Temperature of Screws Increased
Non-significant increase
|
4 procedures
|
|
Number of Procedures in Which Temperature of Screws Increased
Significant increase; procedure stopped
|
2 procedures
|
Adverse Events
Radiofrequency Neurotomy Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place