Endoscopic Electrothermic Procedure of the Sacroiliac Joint

Study Overview
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Brief Summary
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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). 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).

Detailed Description
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Chronic low back pain (CLBP) that lasts for more than six months is estimated to occur in 60-80% of the general population in their lifetime and is associated with substantial healthcare costs. The sacroiliac joint (SIJ) complex is one of the major sources of CLBP, accounting for around 10-33% of the total number of CLBP cases. The SIJ complex consists of the joint capsule, synovia, various muscles and ligamentous structures overlying the join and neuronal structures that innervate the SIJ. Current interventional and surgical treatment options for SIJ complex mediated CLBP include intraarticular and periarticular injection of the joint, SIJ fusion and radio frequency ablation (RFA) of the neuronal structures innervating the SIJ. The described interventional procedures are simple procedures and provides quick pain relief, but the effect is short-lived. In addition, SIJ fusion is an invasive surgical procedure that should be reserved for refractory intractable pain of the SIJ1. New endoscopic electrothermic ablation of the SIJ capsula, synovial and neuronal structures have been utilized in the treatment of facetogenic CLBP in a few number of clinical reports with favorable results, but to our knowledge, the efficacy of this technique when applied to SIJ-associated CLBP has not been reported. In this study, the investigators will utilize endoscopy for the precise microsurgical and ablation (ESIJ) of the potential pain generators associated with the SIJ and evaluate the clinical efficacy of this new technique.

Official Title
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Endoscopic Electrothermic Procedure of the Sacroiliac Joint

Conditions
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Chronic Lower Back Pain (CLBP), SIJ Arthropathy

Intervention / Treatment
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* Device: MultiZYTE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, non-randomized, multi-center study, case series, clinical observation study of minimally invasive surgery for the treatment of SIJ arthropathy and chronic lower back pain (CLBP).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment: Endoscopic ET on SI joint<br>New techniques have been developed and tested to expand the usefulness of minimally invasive spine surgery beyond disk herniation. This includes endoscopic electrothermic ablation which can be used to target SIJ-associated CLBP. A small retrospective study demonstrated significant improvements in Visual Analog Scale and Oswestry Disability Index from pre-operative levels in patients with CLBP associated with the SIJ for up to 21 months following the procedure. However, there has not yet been a prospective study to assess the efficacy of this procedure, and therefore, this is the aim of this study. | Device: MultiZYTE<br>* Subjects can be treated either unilateral or bilateral, depending on their condition and the recommended treatment by the surgeon. The decision is a clinical one and is not influenced by the decision of whether to be included in the study or the subsequent outcomes and QoL analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D-3L | 5 Question Health Questionnaire: patient's rate their mobility, self-care, usual activities, pain/discomfort and anxiety/depression developed by Euroqol Research Foundation. Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems: Dimension 1: Mobility Dimension 2: Self-Care Dimension 3: Usual Activities Dimension 4: Pain/Discomfort Dimension 5: Anxiety/Depression Level 1: indicating no problem Level 2: indicating slight problems Level 3: indicating moderate problems Level 4: indicating severe problems Level 5: indicating extreme problems A total of 3,125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. Lowest Score: 11111 (No problems on any of the 5 dimensions) Highest Score: 55555 (Extreme problems on all of the 5 dimensions) | Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op | 
| Change in Visual Analogue Scale (VAS) | Health Questionnaire: patient's rate their health state on a scale from 0 to 100. Score Range: 0-100mm Low Score = Lower Pain Intensity High Score = Greater Pain Intensity | Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op | 
| Change in Oswestry Disability Index (ODI) | 10 Question Health Questionnaire where patient's rate their level of back pain. Score Range: 0-100% Low Score = Minimal Disability High Score = Severe Disability | Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op |