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

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.
 
ClinicalTrials.gov Identifier: NCT03122899
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

Tracking Information
First Submitted Date  ICMJE April 18, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date December 8, 2021
Actual Study Start Date  ICMJE October 3, 2017
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • 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.
  • Primary Clinical Outcome: Disability due to low back pain [ Time Frame: Comparing baseline to 6 months. ]
    Improvement in Oswestry Disability Index
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • 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.
  • Primary Clinical Outcome: SIJ Pain [ Time Frame: Comparing baseline to 6 months. ]
    Improvement in visual analog sacroiliac joint pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • Bridging Bone [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with bridging bone.
  • Clinically Significant Radiolucency [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with evidence of clinically significant radiolucency.
  • 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.
  • Positive Bone Remodeling [ Time Frame: 6 months, 12 months, and 5 years ]
    Proportion of treated SIJs with positive bone remodeling response.
  • 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
  • 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.
  • QOL [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Improvement from baseline in QOL as measured by EQ-5D
  • 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.
  • Opioid Use [ Time Frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months. ]
    Decrease from baseline in opioid use
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants
Official Title  ICMJE Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants
Brief Summary SALLY studies sacroiliac joint fusion with the iFuse-3D implant.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Sacroiliac Dysfunction
Intervention  ICMJE Device: SIJ fusion with iFuse-3D
Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).
Study Arms  ICMJE
  • SIJ fusion with iFuse 3D with 6 mo CT
    These subjects will get pelvic CT at 6 months post-operatively.
    Intervention: Device: SIJ fusion with iFuse-3D
  • SIJ fusion with iFuse 3D with 12 mo CT
    These subjects will get pelvic CT at 12 months post-operatively.
    Intervention: Device: SIJ fusion with iFuse-3D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03122899
Other Study ID Numbers  ICMJE 300243
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SI-BONE, Inc.
Study Sponsor  ICMJE SI-BONE, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel J Cher, MD SI-BONE, Inc.
PRS Account SI-BONE, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP