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Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681004
First Posted: September 7, 2012
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SI-BONE, Inc.
  Purpose
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.

Condition Intervention
Degenerative Sacroiliitis Sacroiliac Joint Disruption Device: iFuse Implant System Other: Non-surgical management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel group randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INSITE Investigation of Sacroiliac Fusion Treatment

Further study details as provided by SI-BONE, Inc.:

Primary Outcome Measures:
  • Subject Success [ Time Frame: 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:
  • Improvement in SI Joint Pain VAS Score at 1 Month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 SI Joint Pain VAS Score at 12 Months [ Time Frame: 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.

  • Improvement in SI Joint Pain VAS Score at 24 Months [ Time Frame: 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 [ Time Frame: 1 month ]

    Improvement in ODI score of greater than or equal to 15 points, at month 1.

    Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.


  • Improvement in Back Dysfunction [ Time Frame: 3 Months ]

    Improvement in ODI score of greater than or equal to 15 points, at month 3.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.


  • Improvement in Back Dysfunction [ Time Frame: 6 Months ]

    Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.


  • Improvement in Back Dysfunction [ Time Frame: 12 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 Back Dysfunction [ Time Frame: 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 [ Time Frame: 6 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 Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits [ Time Frame: 12 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 Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits [ Time Frame: 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 Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 6 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.


  • Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 12 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.


  • Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 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.


  • Ambulatory Status [ Time Frame: 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.


  • Work Status [ Time Frame: 1 month ]

    Proportion of non-working (due to back pain or other reasons) 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.


  • Work Status [ Time Frame: 3 Months ]

    Non-working subjects (due to back pain or other reasons) 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.


  • Work Status [ Time Frame: 6 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.


  • Work Status [ Time Frame: 12 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.


  • Work Status [ Time Frame: 18 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.


  • Work Status [ Time Frame: 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.


  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 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.


Enrollment: 159
Study Start Date: September 2012
Study Completion Date: June 2017
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iFuse Implant System
Surgical placement of iFuse implants in the affected SI joint
Device: iFuse Implant System
Placement of iFuse implant system via surgery
Active Comparator: Non-Surgical Management
Medications, SI joint injection, physical therapy and RF ablation of SI joint
Other: Non-surgical management
Medications for pain, physical therapy, SI joint injection and RF ablation

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681004


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
BASIC Spine
Newport Beach, California, United States, 92660
United States, Colorado
University of Colorado Denver Health Sciences
Denver, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, United States, 32117
Brain and Spine Center, LLC
Panama City, Florida, United States, 32405
United States, Georgia
Resurgen's Orthopaedics
McDonough, Georgia, United States, 30253
United States, Illinois
Neurosurgery Consultants/ Riverside Hospital
Kankakee, Illinois, United States, 60901
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, United States, 62864
United States, Indiana
Community Neurosurgery Hospital
Indianapolis, Indiana, United States, 46219
United States, Kentucky
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, United States, 40509
United States, Louisiana
Spine institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
HCA Midwest
Kansas City, Missouri, United States, 64132
United States, Oregon
NeuroSpine Institute, LLC
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Wisconsin
Midwest Orthopedic Specialty Hospital
Franklin, Wisconsin, United States, 53132
Aurora Bay Care Medical Center
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Principal Investigator: Daniel J Cher, MD SI-BONE
  More Information

Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: INSITE

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01681004     History of Changes
Other Study ID Numbers: 300103
First Submitted: September 1, 2012
First Posted: September 7, 2012
Results First Submitted: June 22, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SI-BONE, Inc.:
si joint
si joint pain
si joint injury
si joint treatment
si joint injections
si joint inflammation
si joint problems
si joint symptoms
hypermobile si joint
si joint arthritis
si joint pain treatment
inflamed si joint
si joint sclerosis
locked si joint
si joint injuries
si joint disease
si joint infection
sacroiliac joint pelvic pain
sacroiliac joint arthritis treatment

Additional relevant MeSH terms:
Sacroiliitis
Arthritis
Joint Diseases
Musculoskeletal Diseases