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Endoscopic Electrothermic Procedure of the Sacroiliac Joint (ESIJ)

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ClinicalTrials.gov Identifier: NCT03920345
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
MileStone Research Organization
Information provided by (Responsible Party):
joimax, Inc.

Brief Summary:
  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).

Condition or disease Intervention/treatment Phase
Chronic Lower Back Pain (CLBP) SIJ Arthropathy Device: MultiZYTE Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Endoscopic Electrothermic Procedure of the Sacroiliac Joint
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Endoscopy

Arm Intervention/treatment
Experimental: Treatment: Endoscopic ET on SI joint
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
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.




Primary Outcome Measures :
  1. Change in EQ-5D-3L [ Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op ]

    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)


  2. Change in Visual Analogue Scale (VAS) [ Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op ]

    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


  3. Change in Oswestry Disability Index (ODI) [ Time Frame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920345


Contacts
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Contact: Hope Donovan 858-397-5819 adonovan@milestonecro.com
Contact: Meredith Darney 949859-3472 meredith.darney@joimaxusa.com

Locations
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United States, Arizona
Dr. Azmi Nasser Recruiting
Mesa, Arizona, United States, 85206
Contact: Azmi Nasser, DO    602-265-8800    drazminasser@gmail.com   
United States, Minnesota
Dr. Daniel Hanson Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Daniel Hanson    651-324-8693    danielwhanson@yahoo.com   
Dr. Louis Saeger Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Louis Saeger    206-339-3890    paindocuno@msn.com   
Sponsors and Collaborators
joimax, Inc.
MileStone Research Organization
Investigators
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Principal Investigator: Hope Donovan MileStone Research Organization

Publications of Results:
Other Publications:
Jasper GP, Francisco GM, Choi DB, Doberstein CE, Telfeian AE. Clinical Benefits of Ultra- Minimally Invasive Spine Surgery in Awake Obese Patients in an Outpatient Setting : A Retrospective Evaluation of Transforaminal Endoscopic Discectomy with Foraminotomy. JSM Neurosurg Spine. 2014;2(5):1041.
Ibrahim R, Gohlke K, Decker O. Endoscopic Electrothermic (ESIJ) Procedure of the Sacroiliac Joint 21-Month Follow up Stud¡es.; 2016.

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Responsible Party: joimax, Inc.
ClinicalTrials.gov Identifier: NCT03920345     History of Changes
Other Study ID Numbers: MULTI-2018-05-31
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Back Pain
Joint Diseases
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Diseases