Endoscopic Electrothermic Procedure of the Sacroiliac Joint

NCT03920345 | Terminated FDA Device

• 1 other identifier: MULTI-2018-05-31
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

1. 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. 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).

Conditions

Chronic Lower Back Pain (CLBP); SIJ Arthropathy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Treatment: Endoscopic ET on SI joint

EXPERIMENTAL

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

Interventions

MultiZYTE DEVICE

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.

Treatment: Endoscopic ET on SI joint

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• joimax, Inc.: lead
• MileStone Research Organization: collaborator

Study Sites (3)

Dr. Azmi Nasser

Mesa, Arizona, 85206, United States

Location

Dr. Daniel Hanson

Maple Grove, Minnesota, 55369, United States

Location

Dr. Louis Saeger

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (7)

• 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.

  BACKGROUND

• Ibrahim R, Gohlke K, Decker O. Endoscopic Electrothermic (ESIJ) Procedure of the Sacroiliac Joint 21-Month Follow up Stud¡es.; 2016.

  BACKGROUND

• 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.

  PMID: 28105414 RESULT

• 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.

  PMID: 24172188 RESULT

• 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. doi: 10.12659/msm.894870.

  PMID: 26887645 RESULT

• 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.

  PMID: 22705355 RESULT

• 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.

  PMID: 23835307 RESULT

Study Officials

• Hope Donovan

  MileStone Research Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 18, 2019
• Study Start: June 8, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)