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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sacroiliac Joint Disruption; Degenerative Sacroiliitis; Sacro Iliac Joint Pain; Sacroiliac Joint Dysfunction; Sacroiliac Disorder; Sacro-iliac Joints
• Intervention / Treatment: Device: iFuse INTRA Ti Implant System

Detailed Description

PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Director of Clinical Affairs; Phone Number: 408-207-0700; Email: clinicalaffairs.@si-bone.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. ASA score 4 or 5.
2. 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.
3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture.
4. Current diagnosis of cluneal neuralgia.
5. Previous SIJ implant placement, including allograft, on the treated (index) side.
6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement.
7. History of recent (<1 year) major trauma to pelvis.
8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture).
9. Chronic rheumatologic condition (e.g., rheumatoid arthritis).
10. Current diagnosis of fibromyalgia.
11. Known allergy to titanium or titanium alloys.
12. Current local or systemic infection that raises the risk of surgery.
13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
14. Currently pregnant or planning pregnancy in the next 2 years (self-reported).
15. Patient is a prisoner or a ward of the state.
16. Known or suspected active drug or alcohol abuse, including opioids
17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with a Serious Adverse Event (SAE)	Proportion of participants with a serious adverse event classified as probably or definitely related to the study device or procedure	24 months
Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)	Proportion of participants undergoing one or more SSI related to the index procedure.	24 months
Proportion of Treated Sides with Radiographic Evidence of Loosening	Proportion of treated sides showing signs of loosening of INTRA Ti, as evidenced by both radiolucent areas around implant plus bony reaction ("rind") near implant.	24 months
Proportion of Implants with Radiographic Evidence of Device Migration.	Proportion of INTRA Ti implants that show evidence of device migration.	24 months
Proportion of Implants with Radiographic Evidence of Device Breakage.	Proportion of INTRA Ti implants that show breakage.	24 months
Proportion of Participants with Radiographic Evidence of SI Joint Fusion	Radiographic fusion defined as the presence of bony apposition along the bone-implant interface at the index sacroiliac joint(s), as assessed by CT.	12 months

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Stacie Tran, MPH, SI-BONE

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SI-BONE; sacroiliac fusion; INTRA Ti
• Other Study ID Numbers: 303256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are currently no plans to share but IPD may be shared with qualified researchers upon reasonable request, subject to sponsor approval and data use agreements.

Drug and device information, study documents

• 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.: Yes