Sacro Iliac Joint PainPIERCENCT07565545
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
An observational study of Sacro Iliac Joint Pain and Sacro-iliac Joints, run by SI-BONE, Inc..
Trial summary
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacro Iliac Joint Pain, Sacro-iliac Joints, Sacroiliac Disorder
- What is being tested?
- iFuse INTRA Ti Implant System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Known or suspected active drug or alcohol abuse, including opioids
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
- Conditions
- Sacro Iliac Joint Pain, Sacro-iliac Joints, Sacroiliac Disorder, Sacroiliac Joint Dysfunction, Sacroiliac Joint Disruption, Degenerative Sacroiliitis
- Being tested
- iFuse INTRA Ti Implant System
- Keywords
- sacroiliac fusion, SI-BONE, INTRA Ti
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse INTRA Ti Implant SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SIJ Dysfunction treated with INTRA Ti | Patients with sacroiliac joint (SIJ) dysfunction due to various causes refractory to non-surgical management. Receives: Device: iFuse INTRA Ti Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months.
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 24 months
Proportion of Implants with Radiographic Evidence of Device Migration.
Proportion of INTRA Ti implants that show evidence of device migration.
Measured: 24 months
Proportion of Implants with Radiographic Evidence of Device Breakage.
Proportion of INTRA Ti implants that show breakage.
Measured: 24 months
Proportion of Participants with Radiographic Evidence of Fusion
Bony apposition to the implant at 12 months as evaluated by pelvic CT
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacro Iliac Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacie Tran, MPH, Study director, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565545
- Sponsor's protocol ID
- 303256
- Acronym
- PIERCE
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior-Inferior Intra-articular Cortical PiERcing Titanium Implant for SaCroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
- ClinicalTrials.gov ID
- NCT07565545
- Acronym / sponsor ID
- PIERCE / 303256
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
Detailed description
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIJ Dysfunction treated with INTRA Ti | – | Device: iFuse INTRA Ti Implant SystemPatients with sacroiliac joint (SIJ) dysfunction due to various causes refractory to non-surgical management. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFuse INTRA Ti Implant SystemFDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis. | Device | SIJ Dysfunction treated with INTRA Ti |
Primary outcome
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 secondary outcomes
Proportion of Participants with a Serious Adverse Event (SAE)
Time frame: 24 months
Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)
Time frame: 24 months
Proportion of Treated Sides with Radiographic Evidence of Loosening
Time frame: 24 months
Proportion of Implants with Radiographic Evidence of Device Migration.
Time frame: 24 months
Proportion of Implants with Radiographic Evidence of Device Breakage.
Time frame: 24 months
Proportion of Participants with Radiographic Evidence of Fusion
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacie Tran, MPH study director
SI-BONE
Questions about this trial
What is this clinical trial studying?
An observational study of Sacro Iliac Joint Pain and Sacro-iliac Joints, run by SI-BONE, Inc..
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 5 inclusion and 17 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Clinical Affairs (408-207-0700, clinicalaffairs.@si-bone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of safety and performance (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.