Investigation of Sacroiliac Fusion Treatment (INSITE)

SI-BONE, Inc.159 enrolled

Overview

The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.

The intended analysis was to examine differences in responses at 6 months. It was acknowledged that subjects with chronic pain in the NSM arm group might not experience any benefit as there was little evidence at the time that NSM was helpful. The protocol included optional crossover to other treatments, including surgical treatment. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

159

Conditions

Degenerative Sacroiliitis Sacroiliac Joint Disruption

Interventions

iFuse Implant SystemDEVICE

Placement of iFuse implant system via surgery

Non-surgical managementOTHER

Medications for pain, physical therapy, SI joint injection and RF ablation

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21-70 at time of screening 2. Patient has lower back pain for \>6 months inadequately responsive to conservative care 3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following: 1. 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 2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and 3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and 4. One or more of the following: i. SI joint disruption: * Asymmetric SI joint widening on X-ray or CT scan, or * Leakage of contrast on diagnostic arthrography ii. Degenerative sacroiliitis: * Radiographic evidence of SI joint degeneration, including sclerosis, osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or * Due to prior lumbosacral spine fusion 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale\* 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 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. Other known sacroiliac pathology such as: 1. Sacral dysplasia 2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy) 3. Tumor 4. Infection 5. Acute fracture 6. Crystal arthropathy 3. History of recent (\<1 year) major trauma to pelvis 4. Previously diagnosed osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture). Patients meeting the osteoporosis screening criteria identified by the National Osteoporosis Foundation should be screened for osteoporosis with DEXA.\*\*\*\* See Section 3.6.4. 5. Osteomalacia or other metabolic bone disease 6. Chronic rheumatologic condition (e.g., rheumatoid arthritis) 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Chondropathy 9. Known allergy to titanium or titanium alloys 10. Use of medications known to have detrimental effects on bone quality and soft-tissue healing 11. Prominent neurologic condition that would interfere with physical therapy 12. Current local or systemic infection that raises the risk of surgery 13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation. 14. Currently pregnant or planning pregnancy in the next 2 years 15. Patient is a prisoner or a ward of the state. 16. Known or suspected drug or alcohol abuse\*\*\* 17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation

Locations (19)

University of California, San Diego

La Jolla, California, United States

BASIC Spine

Outcomes

Primary Outcomes

Subject Success

Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is \*\*intent to treat\*\*, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.

Time frame: 6 months

Secondary Outcomes

Improvement in SI Joint Pain VAS Score at 1 Month

Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative \& NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

Time frame: 1 month

Improvement in Si Joint Pain VAS Score at 3 Months

Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative \& NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

Time frame: 3 Months

Improvement in SI Joint Pain VAS Score at 6 Months

Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative \& NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

Time frame: 6 Months

Data from ClinicalTrials.gov

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Newport Beach, California, United States

University of Colorado Denver Health Sciences

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Orthopaedic Clinic of Daytona Beach

Daytona Beach, Florida, United States

Brain and Spine Center, LLC

Panama City, Florida, United States

Resurgen's Orthopaedics

McDonough, Georgia, United States

Neurosurgery Consultants/ Riverside Hospital

Kankakee, Illinois, United States

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, United States

Community Neurosurgery Hospital

Indianapolis, Indiana, United States

...and 9 more locations

Improvement in SI Joint Pain VAS Score at 12 Months

Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.

Time frame: 12 Months

Improvement in SI Joint Pain VAS Score at 24 Months

Time frame: 24 Months