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出境医 / 临床实验 / Endoscopic Electrothermic Procedure of the Sacroiliac Joint (ESIJ)

Endoscopic Electrothermic Procedure of the Sacroiliac Joint (ESIJ)

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 16, 2019
Arms and Interventions
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.

Outcome Measures
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



Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
United States, Arizona
Dr. Azmi Nasser
Mesa, Arizona, United States, 85206
United States, Minnesota
Dr. Daniel Hanson
Maple Grove, Minnesota, United States, 55369
Dr. Louis Saeger
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
joimax, Inc.
MileStone Research Organization
Investigators
Layout table for investigator information
Principal Investigator: Hope Donovan MileStone Research Organization
Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE June 8, 2018
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Electrothermic Procedure of the Sacroiliac Joint
Official Title  ICMJE Endoscopic Electrothermic Procedure of the Sacroiliac Joint
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Chronic Lower Back Pain (CLBP)
  • SIJ Arthropathy
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: MultiZYTE
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.
  • Choi WS, Kim JS, Ryu KS, Hur JW, Seong JH, Cho HJ. Endoscopic Radiofrequency Ablation of the Sacroiliac Joint Complex in the Treatment of Chronic Low Back Pain: A Preliminary Study of Feasibility and Efficacy of a Novel Technique. Biomed Res Int. 2016;2016:2834259. doi: 10.1155/2016/2834259. Epub 2016 Dec 25.
  • Smith AG, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Mody MG, Shamie AN. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. 2013 Oct 30;7(1):14. doi: 10.1186/1750-1164-7-14.
  • Pan Z, Ha Y, Yi S, Cao K. Efficacy of Transforaminal Endoscopic Spine System (TESSYS) Technique in Treating Lumbar Disc Herniation. Med Sci Monit. 2016 Feb 18;22:530-9.
  • Gibson JN, Cowie JG, Iprenburg M. Transforaminal endoscopic spinal surgery: the future 'gold standard' for discectomy? - A review. Surgeon. 2012 Oct;10(5):290-6. doi: 10.1016/j.surge.2012.05.001. Epub 2012 Jun 15. Review.
  • Jasper GP, Francisco GM, Telfeian AE. Clinical success of transforaminal endoscopic discectomy with foraminotomy: a retrospective evaluation. Clin Neurol Neurosurg. 2013 Oct;115(10):1961-5. doi: 10.1016/j.clineuro.2013.05.033. Epub 2013 Jul 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
100
Actual Study Completion Date  ICMJE May 16, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920345
Other Study ID Numbers  ICMJE MULTI-2018-05-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party joimax, Inc.
Study Sponsor  ICMJE joimax, Inc.
Collaborators  ICMJE MileStone Research Organization
Investigators  ICMJE
Principal Investigator: Hope Donovan MileStone Research Organization
PRS Account joimax, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP