Endoscopic Electrothermic Procedure of the Sacroiliac Joint

Stopped early · Not applicable

Conditions studied: Chronic Lower Back Pain (CLBP), SIJ Arthropathy

In brief

1. Determine the rate and incidence of peri-operative \& post-operative adverse events (complications, infections, re-operations, re-admissions) in the endoscopic approach for the treatment of SIJ arthropathy and chronic lower back pain (CLBP). 2. Determine the Health-Related Quality of Life (HRQoL) using EQ-5D scale, VAS (Visual Analog Scale) \& ODI (Oswestry Disability Index), outcomes following the endoscopic approach for the treatment of SIJ arthropathy and chronic lower back pain (CLBP) (pre- to post-operative changes).

Key facts

Study ID

NCT03920345

Run by

joimax, Inc.

People needed

5

Starts

2018-06-08

Expected to finish

2019-05-16

Last updated by the study team

2019-07-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject age 18 - 85 years;
• SIJ arthropathy and chronic lower back pain (CLBP);
• Patient to undergo endoscopic electrothermic ablation of spinal levels S1-S3. The L4-L5 and/or L5-S1 facet joint can be included in the ablation per doctor discretion.
• Correct spinal levels (ranging L4-S3) to be treated have been confirmed by 1) diagnostic SIJ injection, followed by 2) diagnostic Medial/Lateral Branch Block at the applicable levels.
• The subject is likely to follow standard of care post-operative follow-up for at least 24 months.

You may not qualify if…

• Patients receiving additional invasive back surgery after the study treatment.
• Inability to complete follow-up visits or required questionnaires.
• Non-compliant patients
• Difficult or impossible communication with the patient
• Breastfeeding, pregnant or patients who plan a pregnancy while participating in the study
• Systemic neurological disorders with mobility limitations (e.g. advanced Parkinson's disease or multiple sclerosis)
• Patients with incompatibilities or known limitations that make participation impossible
• Patients after stabilization with implants on thoracic or lumbar spine.
• Inability to provide informed consent without a legally authorized representative.

Where it is running

• Dr. Azmi Nasser — Mesa, Arizona, United States
• Dr. Daniel Hanson — Maple Grove, Minnesota, United States
• Dr. Louis Saeger — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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