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Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants (SALLY)

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ClinicalTrials.gov Identifier: NCT03122899
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

Brief Summary:
SALLY studies sacroiliac joint fusion with the iFuse-3D implant.

Condition or disease Intervention/treatment Phase
Sacroiliac Dysfunction Device: SIJ fusion with iFuse-3D Not Applicable

Detailed Description:
Participants will all get sacroiliac joint fusion on this study using the iFuse-3D titanium implant, manufactured by SI-BONE, Inc. Participants will be followed for clinical outcomes at pre-planned time points on the trial. Participants will be randomized to CT scan at 6 months or 12 months, and all will also get a CT scan at 5 years, the final visit for the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Minimally invasive sacroiliac joint fusion surgery with iFuse-3D
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2025

Arm Intervention/treatment
SIJ fusion with iFuse 3D with 6 mo CT
These subjects will get pelvic CT at 6 months post-operatively.
Device: SIJ fusion with iFuse-3D
Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).

SIJ fusion with iFuse 3D with 12 mo CT
These subjects will get pelvic CT at 12 months post-operatively.
Device: SIJ fusion with iFuse-3D
Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).




Primary Outcome Measures :
  1. Primary Radiographic Outcome: Bone adherence [ Time Frame: Comparing 6 and 12 month CTs to historical data from other studies. ]
    Percent surface area of the sacral end of the implants to which bone is adherent.

  2. Primary Clinical Outcome: Disability due to low back pain [ Time Frame: Comparing baseline to 6 months. ]
    Improvement in Oswestry Disability Index


Secondary Outcome Measures :
  1. Bridging Bone [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with bridging bone.

  2. Clinically Significant Radiolucency [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with evidence of clinically significant radiolucency.

  3. Adverse Bone Reactions [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with adverse bone reactions at or near the SIJ.

  4. Positive Bone Remodeling [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with positive bone remodeling response.

  5. SIJ Pain [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Improvement from baseline in SIJ pain as measured by Visual Analog Scale

  6. Disability [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Improvement from baseline in disability as measured by Oswestry Disability Index.

  7. QOL [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Improvement from baseline in QOL as measured by EQ-5D

  8. Physical Function [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Improvement from baseline in physical function as measured by active straight leg raise, 5 times sit to stand, transitional timed up and go.

  9. Opioid Use [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Decrease from baseline in opioid use

  10. Serious Adverse Event Rate [ Time Frame: 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Rate of serious adverse events related to the procedure or device.



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

Inclusion Criteria:

  1. Patient age 21-70 at time of screening.
  2. Patient has suspected SI joint pain for greater than or equal to 6 months inadequately responsive to conservative care.
  3. Diagnosis of sacroiliac joint dysfunction on one or two sides to be treated on study that is a direct result of sacroiliac joint disruption and/or degenerative sacroiliitis and is 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) (on any targeted side), and
    2. Patient has positive findings on at least 3 physical examination maneuvers that stress the target SI joint(s) and
    3. Patient has block on any study targeted side with improvement in SI joint pain numeric rating scale (NRS) at 30 or 60 minutes of at least 50% after injection of local anesthetic into any affected SI joint with an immediate pre-block NRS of at least 5.
  4. Baseline Oswestry Disability Index (ODI) score of at least 30%.
  5. Baseline (average over the last week) SI joint pain score of at least 50 on 0-100 mm visual analog scale on any side to be treated under the study.
  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.
  8. Patient's insurance coverage for SI joint treatment has been considered and plan is to submit all study-related healthcare to insurance (or it is the patient's responsibility) (any required preauthorization should be completed prior to randomization on study).
  9. Investigator believes patient is appropriate candidate for surgery using iFuse-3D Implant.

Exclusion Criteria:

  1. Patient has bilateral SI joint symptoms with VAS pain scores ³50 on both sides and patient refuses to undergo bilateral treatment according to the study protocol.
  2. Patient is currently pregnant, actively trying to become pregnant or is planning to become pregnant in the next year.
  3. Severe back or hip pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar vertebral body fracture, piriformis syndrome, femoral acetabular impingement, labral tear or hip osteoarthritis. Patients with low back pain VAS ratings more than 50 should be carefully considered; they should not participate if the investigator believes these non-SIJ conditions would impair improvement from SIJ treatment.
  4. SI joint dysfunction due to an alternative explanation such as:

    1. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
    2. Tumor
    3. Infection
    4. Acute or unstable fracture.
  5. History of recent (<1 year) major non-pregnancy-related trauma to pelvis.
  6. Surgeon believes patient body habitus prevents surgery.
  7. Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
  8. Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture).
  9. Prior diagnosis of tumor in sacrum or ilium.
  10. Unstable fracture of sacrum and or ilium involving the targeted SIJ.
  11. Osteomalacia or other metabolic bone disease.
  12. Diagnosed or suspected chronic rheumatologic condition (e.g., rheumatoid arthritis, lupus).
  13. Any known condition or anatomical deformity or variation that makes treatment with the iFuse-3D Implant infeasible.
  14. Any known health condition that could prevent long-term follow-up required in this study.
  15. Known allergy to titanium or titanium alloys.
  16. Use of medications known to have detrimental effects on bone quality and soft-tissue healing.
  17. Current local or systemic infection that raises the risk of surgery.
  18. Patient currently receiving or seeking short- or long-term worker's compensation related to the SI joint or low back pain, currently receiving disability remuneration related to SI joint or low back pain, and/or currently involved in injury litigation related to the SI joint or low back pain.
  19. Patient is a prisoner or a ward of the state.
  20. Patient has known or suspected active drug or alcohol abuse.
  21. Patient is unwilling to sign the study-associated opioid contract.
  22. Diagnosed uncontrolled psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
  23. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
  24. Patient has known or suspected fibromyalgia.

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): NCT03122899


Contacts
Contact: Daniel J Cher, MD 408-207-0700 dcher@si-bone.com
Contact: Shira M Stone 408-207-0700 sstone@si-bone.com

Locations
United States, California
Memorial Orthopaedic Surgical Group Recruiting
Long Beach, California, United States, 90806
Contact: Maribel Balderas       mbalderas423@gmail.com   
Contact: Nanette Soto       nanettemsoto@gmail.com   
Principal Investigator: Philip S Yuan, MD         
Sub-Investigator: Jennifer L Huie, MMsc, PA-C         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Claire Cofer    303-724-1588    CLAIRE.COFER@UCDENVER.EDU   
Contact: Manishi Patel       Manishi.patel@ucdenver.edu   
Principal Investigator: Vikas V Patel, MD         
Sub-Investigator: Christopher J Kleck, MD         
Sub-Investigator: Susan M Estes, NP-C         
Clin Tech Center for Spine Health Recruiting
Johnstown, Colorado, United States, 80534
Contact: Michaela Zochniak    970-315-4018    research@clintechspine.org   
Principal Investigator: Fernando Techy, MD         
United States, Florida
The B.A.C.K. Center Recruiting
Melbourne, Florida, United States, 32901
Contact: Lisa King, PhD    321-723-7716    lisa.king@thebackcenter.net   
Contact: Kimberly Sellati       Kimberly.Sellati@thebackcenter.net   
Principal Investigator: James Billys, MD         
United States, Illinois
Orthopedic Center of Southern Illinois Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Cristy Buchanan    618-242-3778 ext 7176    cristyb@OCOSI.ORG   
Principal Investigator: Don A Kovalsky, MD         
United States, Kentucky
Bluegrass Orthopaedics Recruiting
Lexington, Kentucky, United States, 40509
Contact: Jim Farris, PA-C    859-263-5140      
Principal Investigator: Harry Lockstadt, H.B.Sc., MD, FRCS (C)         
United States, Louisiana
LSU Health Sciences Center, Department of Neurosurgery Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Erin Fannin, MSPH, CCRC    504-568-2641    efanni@lsuhsc.edu   
Principal Investigator: Gabriel Tender, MD         
Sub-Investigator: Jason Wilson, MD         
United States, Missouri
Columbia Orthopaedic Group Recruiting
Columbia, Missouri, United States, 65201
Contact: Michelle Vogt    573-443-2402 ext 4391    m.vogt@columbiaorthogroup.com   
Principal Investigator: S. Craig Meyer, MD         
United States, Oregon
South Oregon Orthopedics Recruiting
Medford, Oregon, United States, 97504
Contact: Meagan Holte, CMA    541-608-2567    meaganh@oregonorthortho.com   
Principal Investigator: Andy J Kranenburg, MD         
United States, Tennessee
East Tennessee Brain & Spine Center Withdrawn
Johnson City, Tennessee, United States, 37604
United States, Washington
Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Tina Fortney, RN, BSN    425-688-5407    Tina.Fortney@overlakehospital.org   
Contact: Lucille Pierson    425-467-3696    lucille.pierson@overlakehospital.org   
Principal Investigator: Abhineet Chowdhary, MD         
Sub-Investigator: Julie LaCombe, MD         
United States, Wisconsin
Aurora Research Institute Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Taylor Romdenne, BS, CCRP    920-288-3127    taylor.romdenne@aurorabaycare.com   
Principal Investigator: Robert Limoni, MD         
Sub-Investigator: Max Ots, MD         
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Study Director: Daniel J Cher, MD SI-BONE, Inc.

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT03122899     History of Changes
Other Study ID Numbers: 300243
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by SI-BONE, Inc.:
SI-BONE
sacroiliac joint
degenerative sacroiliitis
sacroiliac joint disruption
iFuse