Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes

NCT07565545 | Not Yet Recruiting FDA Device

• 1 other identifier: 303256
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.

Conditions

Sacro Iliac Joint Pain; Sacro-iliac Joints; Sacroiliac Disorder; Sacroiliac Joint Dysfunction; Sacroiliac Joint Disruption; Degenerative Sacroiliitis

Keywords

sacroiliac fusion; SI-BONE; INTRA Ti

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of safety and performance

  The participant is considered a success if all the following criteria are met: * A ≥ 2 point improvement from baseline in SIJ pain on the target side. * Absence of device-related SAE. * Absence of SSI at index procedure.

  6 months.

Secondary Outcomes (6)

• Proportion of Participants with a Serious Adverse Event (SAE)

  24 months

• Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)

  24 months

• Proportion of Treated Sides with Radiographic Evidence of Loosening

  24 months

• Proportion of Implants with Radiographic Evidence of Device Migration.

  24 months

• Proportion of Implants with Radiographic Evidence of Device Breakage.

  24 months

Study Arms (1)

SIJ Dysfunction treated with INTRA Ti

Patients with sacroiliac joint (SIJ) dysfunction due to various causes refractory to non-surgical management.

Device: iFuse INTRA Ti Implant System

Interventions

iFuse INTRA Ti Implant System DEVICE

FDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis.

SIJ Dysfunction treated with INTRA Ti

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sacroiliac joint (SIJ) dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption for at least 6 months refractory to non-surgical care

You may qualify if:

• Age \> 21 years.
• Patient has chronic lower back pain (≥6 months) refractory to non-surgical care.
• Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti.
• Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure.
• Participant has signed study-specific informed consent form.

You may not qualify if:

• ASA score 4 or 5.
• 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.
• Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture.
• Current diagnosis of cluneal neuralgia.
• Previous SIJ implant placement, including allograft, on the treated (index) side.
• Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement.
• History of recent (\<1 year) major trauma to pelvis.
• Previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture).
• Chronic rheumatologic condition (e.g., rheumatoid arthritis).
• Current diagnosis of fibromyalgia.
• Known allergy to titanium or titanium alloys.
• Current local or systemic infection that raises the risk of surgery.
• Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
• Currently pregnant or planning pregnancy in the next 2 years (self-reported).
• Patient is a prisoner or a ward of the state.

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Officials

• Stacie Tran, MPH

  SI-BONE

  STUDY DIRECTOR

Central Study Contacts

Director of Clinical Affairs

CONTACT

408-207-0700; clinicalaffairs.@si-bone.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share