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

NCT03122899 | Completed FDA Device

• 1 other identifier: 300243
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Sacroiliac Dysfunction

Keywords

SI-BONE; sacroiliac joint; degenerative sacroiliitis; sacroiliac joint disruption; iFuse

Outcome Measures

Primary Outcomes (2)

• Primary Radiographic Outcome: Bone adherence

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

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

• Primary Clinical Outcome: Disability due to low back pain

  Improvement in Oswestry Disability Index

  Comparing baseline to 6 months.

Secondary Outcomes (10)

• Bridging Bone

  6 months, 12 months, and 5 years

• Clinically Significant Radiolucency

  6 months, 12 months, and 5 years

• Adverse Bone Reactions

  6 months, 12 months, and 5 years

• Positive Bone Remodeling

  6 months, 12 months, and 5 years

• SIJ Pain

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

Study Arms (2)

SIJ fusion with iFuse 3D with 6 mo CT

OTHER

These subjects will get pelvic CT at 6 months post-operatively.

Device: SIJ fusion with iFuse-3D

SIJ fusion with iFuse 3D with 12 mo CT

OTHER

These subjects will get pelvic CT at 12 months post-operatively.

Device: SIJ fusion with iFuse-3D

Interventions

SIJ fusion with iFuse-3D DEVICE

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

SIJ fusion with iFuse 3D with 12 mo CT; SIJ fusion with iFuse 3D with 6 mo CT

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (11)

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Clin Tech Center for Spine Health

Johnstown, Colorado, 80534, United States

Location

The B.A.C.K. Center

Melbourne, Florida, 32901, United States

Location

Orthopedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

Bluegrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

LSU Health Sciences Center, Department of Neurosurgery

New Orleans, Louisiana, 70112, United States

Location

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

Location

South Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Aurora Research Institute

Green Bay, Wisconsin, 54311, United States

Location

Related Publications (1)

• 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.

  PMID: 38081463 DERIVED

Study Officials

• Daniel J Cher, MD

  SI-BONE, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Minimally invasive sacroiliac joint fusion surgery with iFuse-3D

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: October 3, 2017
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (11)