Investigation of Sacroiliac Fusion Treatment (INSITE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01681004
First received: September 1, 2012
Last updated: June 26, 2014
Last verified: June 2014
  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 Phase
Degenerative Sacroiliitis
Sacroiliac Joint Disruption
Device: iFuse Implant System
Other: Non-surgical management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Improvement in Si joint pain [ Time Frame: Screening, 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Improvement in SI joint pain VAS score at post-operative visits

  • Improvement in back dysfunction [ Time Frame: Screening, 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Improvement in ODI at post-operative visits

  • Improvement in quality of life [ Time Frame: Baseline, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Improvement in QOL as measured by SF-36 PCS and ED-5D at post-operative visits

  • Ambulatory status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ] [ Designated as safety issue: No ]
    Time to full ambulation amongst those without full ambulation at baseline

  • Work status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ] [ Designated as safety issue: No ]
    Proportion of non-working subjects who return to work

  • Serious adverse events [ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
    Any event meeting ISO14155 definition for serious adverse event at following timepoints: 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.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 06519
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
Mt. 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.
  More Information

No publications provided

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01681004     History of Changes
Other Study ID Numbers: 300103
Study First Received: September 1, 2012
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014