Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain

PHASE4RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

August 15, 2022

Primary Completion Date

August 30, 2026

Study Completion Date

June 30, 2027

Conditions
Sacroiliac Joint ComplexLow Back Pain
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (3)

84009

RECRUITING

University of Utah South Jordan Health Center, South Jordan

84025

RECRUITING

University of Utah Farmington Health Center, Farmington

84108

RECRUITING

University of Utah Orthopaedic Center, Salt Lake City

All Listed Sponsors
collaborator

Stratus Medical, INC

UNKNOWN

lead

University of Utah

OTHER

NCT05409443 - Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain | Biotech Hunter | Biotech Hunter