116
Participants
Start Date
August 15, 2022
Primary Completion Date
August 30, 2026
Study Completion Date
June 30, 2027
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
"* Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.~* The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal."
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
"* To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.~* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The analog clock positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).~* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location."
RECRUITING
University of Utah South Jordan Health Center, South Jordan
RECRUITING
University of Utah Farmington Health Center, Farmington
RECRUITING
University of Utah Orthopaedic Center, Salt Lake City
Stratus Medical, INC
UNKNOWN
University of Utah
OTHER