Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Ochsner Health System
- Primary Endpoint
- Treatment success
Study Overview
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.
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 International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
Background
Sacroiliac joint (SIJ) dysfunction is a common pain condition involving the buttock and may irradiate in the low back, groin and/or lower extremity. About one in five patients with low back pain is estimated to have SI joint pain. The economic burden of SIJ pain is high in the United States and there is a need for more cost effective treatment options. There is a lack of relevant high quality studies that compared nonsurgical and surgical treatment for SI joint dysfunction.
Sacroiliac joint (SIJ) dysfunction has been estimated to be the origin of lower back pain in 13 to 30% of patients. SIJ pain is usually referred to the buttock, low back, groin and/or lower extremity. SIJ osteoarthritis, trauma, SIJ degeneration following lumbar fusion and postpartum SIJ dysfunction are common causes of SIJ pain found in a clinical setting. Other less common causes for SIJ pain include inflammatory sacroiliitis, infective sacroiliitis, insufficiency stress fractures and neoplasia.
Diagnostic evidences for SIJ dysfunction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sacroiliac joint fusion
The subject will receive a sacroiliac joint fusion
Intervention: Sacroiliac joint fusion (Procedure)
Sacroiliac radio frequency ablation
The subject will receive a sacroiliac joint radiofrequency ablation
Intervention: Sacroiliac joint radiofrequency ablation (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Radiofrequency ablation subgroups analysis(6 months after the intervention)
- 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)
- 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)
- Mean changes from baseline in SF-36 mental component summary score(6 months after the intervention)
Investigators
Daniel Denis
Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine
Ochsner Health System