Clinical trial NCT03920345: Endoscopic Electrothermic Procedure of the Sacroiliac Joint
Official title: Endoscopic Electrothermic Procedure of the Sacroiliac Joint
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Lower Back Pain (CLBP)
SIJ Arthropathy
Lead sponsor: joimax, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MileStone Research Organization
First posted: 2019-04-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in EQ-5D-3L
timeFrame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op
measure: Change in Visual Analogue Scale (VAS)
timeFrame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Pre-Op, Peri-Op, 6-weeks, 3-months, 6-months, 12-months, 24-months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Dr. Azmi Nasser
state: Arizona
city: Maple Grove
country: United States
facility: Dr. Daniel Hanson
state: Minnesota
city: Minneapolis
country: United States
facility: Dr. Louis Saeger
state: Minnesota
Study officials:
affiliation: MileStone Research Organization
name: Hope Donovan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ibrahim R, Gohlke K, Decker O. Endoscopic Electrothermic (ESIJ) Procedure of the Sacroiliac Joint 21-Month Follow up Stud¡es.; 2016.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.