Sacroiliac Joint Fusion Comparison Study

NCT03230279 | Withdrawn

• 1 other identifier: X-99
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or radiofrequency ablation. The radio frequency ablation is performed using either conventional or "cooled" techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at comparing treatment success at 6-month follow-up time-point after minimally invasive sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.

Conditions

Sacroiliac Joint Somatic Dysfunction; Sacroiliac; Spondylitis

Keywords

Sacroiliac pain; Low back pain

Outcome Measures

Primary Outcomes (1)

• Treatment success

  Comparison in the proportion of subjects having a success between groups at 6-month follow-up time-point. Treatment success is defined as a ≥ 50% decrease in VAS pain score; a 10-point increase in SF-36BP (amelioration); a 15-point decrease in ODI (amelioration); absence of device-related serious adverse events; absence of focal neurological deficit or neuropathic pain related to lumbosacral nerve roots injury and absence of surgical reintervention for SIJ pain (revision, removal of hardware, additional fixation)

  6 months after the intervention

Secondary Outcomes (6)

• Cost-effectiveness between SIJ fusion and radio frequency ablation

  6 months after the intervention

• Mean changes from baseline in visual analog score for pain

  6 months after the intervention

• Radiofrequency ablation subgroups analysis

  6 months after the intervention

• Mean changes from baseline in Oswestry Disability Index score

  6 months after the intervention

• Mean changes from baseline in SF-36 physical component summary score

  6 months after the intervention

Study Arms (2)

Sacroiliac joint fusion

ACTIVE COMPARATOR

The subject will receive a sacroiliac joint fusion

Procedure: Sacroiliac joint fusion

Sacroiliac radio frequency ablation

ACTIVE COMPARATOR

The subject will receive a sacroiliac joint radiofrequency ablation

Procedure: Sacroiliac joint radiofrequency ablation

Interventions

Sacroiliac joint fusion PROCEDURE

Minimally invasive SIJ fusion will be performed under general anesthesia with fluoroscopy. Using SI-LOK®, Sacroiliac Joint Fixation System, Globus Medical Inc. (Audubon, PA), this procedure involve placement of 2 to 3 implants across the SIJ to achieve stabilization and arthrodesis.

Also known as: Minimally invasive sacroiliac joint arthrodesis

Sacroiliac joint fusion

Sacroiliac joint radiofrequency ablation PROCEDURE

Sacroiliac joint radio frequency ablation will be performed using either conventional or cooled radiofrequency ablation techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. The choice between conventional or cooled RFN will be determined by the provider expertise.

Also known as: Sacroiliac joint neurotomy

Sacroiliac radio frequency ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age ≥ 18 years old
• Subject is willing and able to give informed consent for participation in the study
• Unilateral or bilateral SIJ pain for more than 50 days
• Persistent SIJ pain despite a trial of physical therapy for SI joint pain
• Agreement to avoid conception during trial
• Average VAS of at least 50 mm
• Minimal ODI score of at least 40%
• Etiology of SIJ dysfunction: osteoarthritis, past surgical history of lumbar or lumbosacral fusion, traumatic injury, post-partum.
• The SIJ pain can not be explained by a lumbar spine pathology seen on MRI: (disc herniation, lateral recess stenosis, moderate or severe spinal stenosis, synovial cyst, mass)
• Successful SIJ injection based on criteria discussed in recruitment section

You may not qualify if:

• Neurological deficit
• History of cancer
• Active spinal or systemic infection
• Past medical history or active psychiatric condition
• Prohibited drug use
• Subject with pacemaker
• Pregnancy or Breastfeeding

Sponsors & Collaborators

• Ochsner Health System: lead
• Globus Medical Inc: collaborator

Related Publications (20)

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• Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.

  PMID: 18996232 BACKGROUND

• Capobianco R, Cher D; SIFI Study Group. Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial. Springerplus. 2015 Oct 5;4:570. doi: 10.1186/s40064-015-1359-y. eCollection 2015.

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• Longo UG, Loppini M, Berton A, Laverde L, Maffulli N, Denaro V. Degenerative changes of the sacroiliac joint after spinal fusion: an evidence-based systematic review. Br Med Bull. 2014 Dec;112(1):47-56. doi: 10.1093/bmb/ldu030. Epub 2014 Oct 29.

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• Unoki E, Abe E, Murai H, Kobayashi T, Abe T. Fusion of Multiple Segments Can Increase the Incidence of Sacroiliac Joint Pain After Lumbar or Lumbosacral Fusion. Spine (Phila Pa 1976). 2016 Jun;41(12):999-1005. doi: 10.1097/BRS.0000000000001409.

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  PMID: 26632100 BACKGROUND

• Irwin RW, Watson T, Minick RP, Ambrosius WT. Age, body mass index, and gender differences in sacroiliac joint pathology. Am J Phys Med Rehabil. 2007 Jan;86(1):37-44. doi: 10.1097/phm.0b013e31802b8554.

  PMID: 17304687 BACKGROUND

• Simopoulos TT, Manchikanti L, Gupta S, Aydin SM, Kim CH, Solanki D, Nampiaparampil DE, Singh V, Staats PS, Hirsch JA. Systematic Review of the Diagnostic Accuracy and Therapeutic Effectiveness of Sacroiliac Joint Interventions. Pain Physician. 2015 Sep-Oct;18(5):E713-56.

  PMID: 26431129 BACKGROUND

• Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19.

  PMID: 19101212 BACKGROUND

• Hungerford B, Gilleard W, Hodges P. Evidence of altered lumbopelvic muscle recruitment in the presence of sacroiliac joint pain. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1593-600.

  PMID: 12865851 BACKGROUND

• O'Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A. Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine (Phila Pa 1976). 2002 Jan 1;27(1):E1-8. doi: 10.1097/00007632-200201010-00015.

  PMID: 11805650 BACKGROUND

• Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.

  PMID: 18648237 BACKGROUND

• Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.

  PMID: 22299761 BACKGROUND

• Cheng J, Pope JE, Dalton JE, Cheng O, Bensitel A. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Clin J Pain. 2013 Feb;29(2):132-7. doi: 10.1097/AJP.0b013e3182490a17.

  PMID: 22688606 BACKGROUND

• Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H; SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. 2016 May;6(3):257-69. doi: 10.1055/s-0035-1562912. Epub 2015 Aug 11.

  PMID: 27099817 BACKGROUND

• Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN; INSITE Study Group. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1. doi: 10.1227/NEU.0000000000000988.

  PMID: 26291338 BACKGROUND

• Whang P, Cher D, Polly D, Frank C, Lockstadt H, Glaser J, Limoni R, Sembrano J. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.

  PMID: 25785242 BACKGROUND

• Ackerman SJ, Polly DW Jr, Knight T, Schneider K, Holt T, Cummings J. Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States Medicare population: potential economic implications of a new minimally-invasive technology. Clinicoecon Outcomes Res. 2013 Nov 20;5:575-87. doi: 10.2147/CEOR.S52967. eCollection 2013.

  PMID: 24348055 BACKGROUND

MeSH Terms

Conditions

Spondylitis; Low Back Pain

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel R Denis, MD-MSc

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine

Model Details: Study Population: Chronic SIJ dysfunction patients presenting at selected Ochsner Health System healthcare centers Recruiting mode: Participation will be offered by the principal investigator or the sub-investigators during an outpatient visit in the neurosurgery or pain management clinic.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 26, 2017
• Study Start: September 1, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share