Status:
WITHDRAWN
Sacroiliac Joint Fusion Comparison Study
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
Globus Medical Inc
Conditions:
Sacroiliac Joint Somatic Dysfunction
Sacroiliac; Spondylitis
Eligibility:
All Genders
18-100 years
Phase:
NA
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" tech...
Detailed Description
Introduction This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and Inte...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03230279
Start Date
September 1 2018
End Date
September 1 2024
Last Update
August 22 2018
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