Overview

This trial is active, not recruiting.

Condition sacroiliac joint pain
Treatments ifuse implant system, conservative management
Sponsor SI-BONE, Inc.
Start date June 2013
End date December 2015
Trial size 100 participants
Trial identifier NCT01741025, 300134

Summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Surgical placement of iFuse implants in the affected SI joint
ifuse implant system
Placement of iFuse implant system via surgery
(Active Comparator)
Medications, physical therapy, information
conservative management
Medications for pain, physical therapy, cognitive behavour therapy

Primary Outcomes

Measure
The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment
time frame: 6 months

Secondary Outcomes

Measure
Change from baseline in lower back pain (VAS)
time frame: 1, 3, 12 and 24 months
Change from baseline in leg pain (VAS
time frame: 1, 3, 6, 12 and 24 months
Change in disability due to back pain (ODI
time frame: 3, 6, 12 and 24 months
Change in quality of life (EQ-5D
time frame: 3, 6, 12 and 24 months
Change in ambulatory and work status
time frame: 1, 3, 6, 12 and 24 months
Change in depression score (Zung Depression Scale
time frame: 3, 6, 12 and 24 months
Change in objective functional test (ASLR
time frame: 3, 6, 12 and 24 months
Change in walking distance
time frame: 3, 6, 12 and 24 months
Patient satisfaction and self-rating of disease state
time frame: 3, 6, 12 and 24 months
Serious adverse events
time frame: during 24 months
Device breakage, loosening and migration
time frame: 12 months

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion Criteria: 1. Age 21-70 at time of screening 2. Patient has lower back pain for >6 months or >18 months for pregnancy induced lower back pain 3. Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test <6 months ago) 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline lower back pain score of at least 50 on 0-100 point VAS 6. Patient has signed study-specific informed consent form 7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements Exclusion Criteria: 1. Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture 2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy 3. History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring. 4. Spine surgery during the past 12 months. 5. Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) 6. Documented osteomalacia or other metabolic bone disease 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Known allergy to titanium or titanium alloys 9. Use of medications known to have detrimental effects on bone quality and soft-tissue healing 10. Prominent neurologic condition that would interfere with physical therapy 11. Current systemic infection or local infection at the SI joint 12. Currently pregnant or planning pregnancy in the next year 13. Known or suspected drug or alcohol abuse 14. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 15. Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery

Additional Information

Official title A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.
Description This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by SI-BONE, Inc..