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Sacroiliac DysfunctionSALLYNCT03122899

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

A study testing SIJ fusion with iFuse-3D in people with Sacroiliac Dysfunction, run by SI-BONE, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SALLY studies sacroiliac joint fusion with the iFuse-3D implant. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Sacroiliac Dysfunction
What is being tested?
SIJ fusion with iFuse-3D
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
11 sitesUnited States
Study dates
3 Oct 2017to 19 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age 21-70 at time of screening.
  • Patient has suspected SI joint pain for greater than or equal to 6 months inadequately responsive to conservative care.
  • 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:
  • 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
  • Patient has positive findings on at least 3 physical examination maneuvers that stress the target SI joint(s) and
  • 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.
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  • Baseline Oswestry Disability Index (ODI) score of at least 30%.
  • 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.
  • 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.
  • 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).
  • Investigator believes patient is appropriate candidate for surgery using iFuse-3D Implant.

Who cannot join

  • 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.
  • Patient is currently pregnant, actively trying to become pregnant or is planning to become pregnant in the next year.
  • 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.
  • SI joint dysfunction due to an alternative explanation such as:
  • Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
  • Tumor
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  • Infection
  • Acute or unstable fracture.
  • History of recent (<1 year) major non-pregnancy-related trauma to pelvis.
  • Surgeon believes patient body habitus prevents surgery.
  • Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
  • Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture).
  • Prior diagnosis of tumor in sacrum or ilium.
  • Unstable fracture of sacrum and or ilium involving the targeted SIJ.
  • Osteomalacia or other metabolic bone disease.
  • Diagnosed or suspected chronic rheumatologic condition (e.g., rheumatoid arthritis, lupus).
  • Any known condition or anatomical deformity or variation that makes treatment with the iFuse-3D Implant infeasible.
  • Any known health condition that could prevent long-term follow-up required in this study.
  • Known allergy to titanium or titanium alloys.
  • Use of medications known to have detrimental effects on bone quality and soft-tissue healing.
  • Current local or systemic infection that raises the risk of surgery.
  • 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.
  • Patient is a prisoner or a ward of the state.
  • Patient has known or suspected active drug or alcohol abuse.
  • Patient is unwilling to sign the study-associated opioid contract.
  • Diagnosed uncontrolled 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.
  • Patient has known or suspected fibromyalgia.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Columbia Orthopaedic Group

    Columbia, Missouri, 65201

  • Aurora Research Institute

    Green Bay, Wisconsin, 54311

  • Clin Tech Center for Spine Health

    Johnstown, Colorado, 80534

  • Bluegrass Orthopaedics

    Lexington, Kentucky, 40509

  • Memorial Orthopaedic Surgical Group

    Long Beach, California, 90806

  • South Oregon Orthopedics

    Medford, Oregon, 97504

  • The B.A.C.K. Center

    Melbourne, Florida, 32901

  • Orthopedic Center of Southern Illinois

    Mount Vernon, Illinois, 62864

  • LSU Health Sciences Center, Department of Neurosurgery

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

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

Read the 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.

Being tested
SIJ fusion with iFuse-3D
Keywords
SI-BONE, sacroiliac joint, degenerative sacroiliitis, sacroiliac joint disruption, iFuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIJ fusion with iFuse-3DDevice

    Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).

Study groups in NCT03122899
Study groupRoleWhat they receive
SIJ fusion with iFuse 3D with 6 mo CTOtherThese subjects will get pelvic CT at 6 months post-operatively.
Receives: Device: SIJ fusion with iFuse-3D
SIJ fusion with iFuse 3D with 12 mo CTOtherThese subjects will get pelvic CT at 12 months post-operatively.
Receives: Device: SIJ fusion with iFuse-3D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Radiographic Outcome: Bone adherence

    Percent surface area of the sacral end of the implants to which bone is adherent.

    Measured: Comparing 6 and 12 month CTs to historical data from other studies.

  2. Primary Clinical Outcome: Disability due to low back pain

    Improvement in Oswestry Disability Index

    Measured: Comparing baseline to 6 months.

Secondary outcomes (10)

  1. Bridging Bone

    Proportion of treated SIJs with bridging bone.

    Measured: 6 months, 12 months, and 5 years

  2. Clinically Significant Radiolucency

    Proportion of treated SIJs with evidence of clinically significant radiolucency.

    Measured: 6 months, 12 months, and 5 years

  3. Adverse Bone Reactions

    Proportion of treated SIJs with adverse bone reactions at or near the SIJ.

    Measured: 6 months, 12 months, and 5 years

  4. Positive Bone Remodeling

    Proportion of treated SIJs with positive bone remodeling response.

    Measured: 6 months, 12 months, and 5 years

  5. SIJ Pain

    Improvement from baseline in SIJ pain as measured by Visual Analog Scale

    Measured: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

  6. Disability

    Improvement from baseline in disability as measured by Oswestry Disability Index.

    Measured: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

  7. QOL

    Improvement from baseline in QOL as measured by EQ-5D

    Measured: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

  8. Physical Function

    Improvement from baseline in physical function as measured by active straight leg raise, 5 times sit to stand, transitional timed up and go.

    Measured: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

  9. Opioid Use

    Decrease from baseline in opioid use

    Measured: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

  10. Serious Adverse Event Rate

    Rate of serious adverse events related to the procedure or device.

    Measured: 3 mo, 6 mo, 12 mo, 24 mo, 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study start3 Oct 2017
  3. Primary completion19 Jun 2024
  4. Study completion19 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Minimally invasive sacroiliac joint fusion surgery with iFuse-3D
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122899
Sponsor's protocol ID
300243
Acronym
SALLY
Status last verified
Jun 2025
First submitted
18 Apr 2017
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.

    PubMed 38081463

Questions about this trial

What is this clinical trial studying?

A study testing SIJ fusion with iFuse-3D in people with Sacroiliac Dysfunction, run by SI-BONE, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Radiographic Outcome: Bone adherence (time frame: Comparing 6 and 12 month CTs to historical data from other studies.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03122899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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