Investigation of Sacroiliac Fusion Treatment (INSITE)

Not Applicable

Completed

Conditions: Degenerative Sacroiliitis
Sacroiliac Joint Disruption

Interventions: Other: Non-surgical management
Device: iFuse Implant System

Registration Number: NCT01681004

Lead Sponsor: SI-BONE, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 159

Inclusion Criteria

Age 21-70 at time of screening
Patient has lower back pain for >6 months inadequately responsive to conservative care
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
Baseline Oswestry Disability Index (ODI) score of at least 30%
Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale*
Patient has signed study-specific informed consent form
Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria

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**
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
History of recent (<1 year) major trauma to pelvis
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.
Osteomalacia or other metabolic bone disease
Chronic rheumatologic condition (e.g., rheumatoid arthritis)
Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
Chondropathy
Known allergy to titanium or titanium alloys
Use of medications known to have detrimental effects on bone quality and soft-tissue healing
Prominent neurologic condition that would interfere with physical therapy
Current local or systemic infection that raises the risk of surgery
Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
Currently pregnant or planning pregnancy in the next 2 years
Patient is a prisoner or a ward of the state.
Known or suspected drug or alcohol abuse***
Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Surgical Management	Non-surgical management	Medications, SI joint injection, physical therapy and RF ablation of SI joint
iFuse Implant System	iFuse Implant System	Surgical placement of iFuse implants in the affected SI joint

Primary Outcome Measures

Name	Time	Method
Subject Success	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in SI Joint Pain VAS Score at 1 Month	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.
Improvement in Si Joint Pain VAS Score at 3 Months	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.
Improvement in SI Joint Pain VAS Score at 6 Months	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.
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits	24 months	Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
Work Status	24 Months	Non-working subjects who return to work Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
Ambulatory Status	24 months (surgical group), 6 months (non-surgical group)	Time to full ambulation among those without full ambulation at baseline. 60 days was the median of time to full ambulation for the iFuse implant System arm.
Improvement in SI Joint Pain VAS Score at 24 Months	24 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.
Improvement in Back Dysfunction	24 Months	Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits	24 months	Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function). Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
Improvement in SI Joint Pain VAS Score at 12 Months	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.
Number of Participants With Serious Adverse Events (SAEs)	Procedure, discharge, 1, 3, 6, 12, 18 and 24 months	Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.

Trial Locations

Locations (19): Brain and Spine Center, LLC
🇺🇸
Panama City, Florida, United States
University of California, San Diego
🇺🇸
La Jolla, California, United States
Bluegrass Orthopaedics & Hand Care Research
🇺🇸
Lexington, Kentucky, United States
Neurosurgery Consultants/ Riverside Hospital
🇺🇸
Kankakee, Illinois, United States
NeuroSpine Institute, LLC
🇺🇸
Eugene, Oregon, United States
Midwest Orthopedic Specialty Hospital
🇺🇸
Franklin, Wisconsin, United States
Resurgen's Orthopaedics
🇺🇸
McDonough, Georgia, United States
BASIC Spine
🇺🇸
Newport Beach, California, United States
Spine institute of Louisiana
🇺🇸
Shreveport, Louisiana, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Orthopaedic Clinic of Daytona Beach
🇺🇸
Daytona Beach, Florida, United States
Orthopaedic Center of Southern Illinois
🇺🇸
Mount Vernon, Illinois, United States
Aurora Bay Care Medical Center
🇺🇸
Green Bay, Wisconsin, United States
Community Neurosurgery Hospital
🇺🇸
Indianapolis, Indiana, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
University of Colorado Denver Health Sciences
🇺🇸
Denver, Colorado, United States
HCA Midwest
🇺🇸
Kansas City, Missouri, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States