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

April 27, 2026 updated by: SI-BONE, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite endpoint of safety and performance
Time Frame: 6 months.

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants with a Serious Adverse Event (SAE)
Time Frame: 24 months
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)
Time Frame: 24 months
Proportion of participants undergoing one or more SSI related to the index procedure.
24 months
Proportion of Treated Sides with Radiographic Evidence of Loosening
Time Frame: 24 months
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.
Time Frame: 24 months
Proportion of INTRA Ti implants that show evidence of device migration.
24 months
Proportion of Implants with Radiographic Evidence of Device Breakage.
Time Frame: 24 months
Proportion of INTRA Ti implants that show breakage.
24 months
Proportion of Participants with Radiographic Evidence of SI Joint Fusion
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SI-BONE, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stacie Tran, MPH, SI-BONE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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