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Trial record 1 of 1 for:    11805650 [PUBMED-IDS]
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Sacroiliac Joint Fusion Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03230279
Recruitment Status : Withdrawn (Was not financed, Sponsor withdrawn)
First Posted : July 26, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Globus Medical Inc
Information provided by (Responsible Party):
Daniel Denis, Ochsner Health System

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.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Somatic Dysfunction Sacroiliac; Spondylitis Procedure: Sacroiliac joint fusion Procedure: Sacroiliac joint radiofrequency ablation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Arm Intervention/treatment
Active Comparator: Sacroiliac joint fusion
The subject will receive a sacroiliac joint fusion
Procedure: Sacroiliac joint fusion
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.
Other Name: Minimally invasive sacroiliac joint arthrodesis

Active Comparator: Sacroiliac radio frequency ablation
The subject will receive a sacroiliac joint radiofrequency ablation
Procedure: Sacroiliac joint radiofrequency ablation
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.
Other Name: Sacroiliac joint neurotomy




Primary Outcome Measures :
  1. Treatment success [ Time Frame: 6 months after the intervention ]
    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)


Secondary Outcome Measures :
  1. Cost-effectiveness between SIJ fusion and radio frequency ablation [ Time Frame: 6 months after the intervention ]
    Cost-effectiveness comparison between groups. Cost-effectiveness is measured using the SF-6D utility score

  2. Mean changes from baseline in visual analog score for pain [ Time Frame: 6 months after the intervention ]
    Comparison of mean changes from baseline between groups in VAS

  3. Radiofrequency ablation subgroups analysis [ Time Frame: 6 months after the intervention ]
    Subgroups analysis will be carried on between conventional and cooled radio frequency ablation to attempt to determine if any effect is attributable to one form of RFN or the other

  4. Mean changes from baseline in Oswestry Disability Index score [ Time Frame: 6 months after the intervention ]
    Comparison of mean changes from baseline between groups in ODI score

  5. Mean changes from baseline in SF-36 physical component summary score [ Time Frame: 6 months after the intervention ]
    Comparison of mean changes from baseline between groups in SF-36 physical component summary score

  6. Mean changes from baseline in SF-36 mental component summary score [ Time Frame: 6 months after the intervention ]
    Comparison of mean changes from baseline between groups in SF-36 mental component summary score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Once the informed consent has been obtained, the following screening procedures/tests will be performed:

  • Local anesthetic sacroiliac joint block and steroid injection performed by a qualified Ochsner pain management provider in less than 3 months following the consent date
  • The subject will rate his pain level using the VAS at 2, 4, 6, 8 and 10 hours after the sacroiliac joint block and steroid injection
  • Patient will be excluded from the study if they do not meet this criteria: VAS defined as at least 75% pain relief that is sustained for at least 2 hours in a 10 hours period after the block
  • Sacroiliac joint injection will be done without any analgesics but anti anxiety medication can be used on case by case based
  • The subject will attend a follow-up visit at 6 weeks after the SIJ block and steroid injection. During this visit if the subject's VAS has recurred to at least 50mm the patient will be randomized in either sacroiliac joint fusion or radiofrequency ablation.
  • Subjects with VAS smaller than 50mm will be seen at 12 weeks of follow-up. During this visit if the subject's VAS has recurred to at least 50mm the patient will be randomized in either sacroiliac joint fusion or radiofrequency ablation. Subjects with smaller that 50mm VAS will be excluded from randomization at this time point.

Inclusion Criteria:

Participation will be offered by treating physicians during an outpatient visit in the neurosurgery or pain management clinic. Subjects need to meet all inclusion criteria in order to participate in the study.

  • 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

Exclusion Criteria:

All participants meeting any of the exclusion criteria at baseline will be excluded from study participation.

  • 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

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): NCT03230279


Sponsors and Collaborators
Ochsner Health System
Globus Medical Inc
Investigators
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Principal Investigator: Daniel R Denis, MD-MSc Ochsner Health System

Publications:

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Responsible Party: Daniel Denis, Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03230279     History of Changes
Other Study ID Numbers: X-99
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
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: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Daniel Denis, Ochsner Health System:
Sacroiliac pain
Low back pain

Additional relevant MeSH terms:
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Spondylitis
Ankylosis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases