Fracture; PelvicREBARNCT07530497
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
An observational study of Fracture; Pelvic and Insufficiency Fractures, run by SI-BONE, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture
- What is being tested?
- iFuse TORQ TNT Implant System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Aug 2026to Aug 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.
Who may be able to join
- ≥ 60 years of age at screening
- Pelvic pain correlating with fracture location that began EITHER within 6 weeks of a known low-energy traumatic event, OR pelvic insufficiency fracture with pain that is limiting mobility
- Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location
- Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT
- Patient and/or patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent
- Patient agrees to comply with study schedule of assessments
- Patient and/or patient's proxy can complete study-related surveys
- Patient was able to ambulate prior to index fracture
Who cannot join
- Any known anatomic issues that could prevent placement of iFuse TORQ TNT
- Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s)
- Patient requires lumbosacral pelvic fixation as part of index procedure
- Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation or regaining of physical function related to pelvic fracture and is unable to provide a health care proxy to complete study assessments.
- Estimated lifespan < 12 months
- Presence of tumor, lytic lesion, infection, or soft tissues that precludes safe internal fixation
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- Not candidate for surgery due to underlying medical illness
- Social situation that makes 12-month follow-up unlikely
- History of recent (within 1 year) non-index pelvic fracture with non-union
- Other clinically active fragility fracture of spine, hip or arms/legs that could impair recovery from sacral fracture
- Known allergy to titanium or titanium alloys
- Known or suspected active drug or alcohol abuse, including opioids
- Patient is a prisoner or ward of the state
- Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Twin Cities Orthopedics
Edina, Minnesota, 55435
CRC, 952-456-7136, kaylaseiffert@TCOmn.com
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
CRC, (507) 284-1003, Hoplin.Matthew@mayo.edu
- Recruiting
Orthopaedic Associates of Reading
Wyomissing, Pennsylvania, 19610
Principal Investigator, 610-376-8671, michels1331@gmail.com
About this study
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
Read the detailed description
REBAR is a prospective, multicenter, single arm, post-market observational study conducted in a real-world setting on the usage of iFuse TORQ TNT.
- Conditions
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction
- Being tested
- iFuse TORQ TNT Implant System
- Keywords
- Fragility Fracture, pelvic fracture, Osteoporotic pelvic fracture, Fragility Fracture of the pelvis
- Medical subject headings
- Hip Fractures, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse TORQ TNT Implant SystemDevice
FDA-clear implant used for fracture fixation of the pelvis, including acute, non-acute, and non-traumatic fractures and sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
| Study group | Role | What they receive |
|---|---|---|
| FFP using iFuse TORQ TNT. | Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT. Receives: Device: iFuse TORQ TNT Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure
The participant is considered a success if all of the following apply:
- No breakage of study device on any radiographic study
- No detectable migration or backout of study device compared to immediate postop or end-of-procedure view
- No revision surgery related to the study device
Measured: 6-months
Secondary outcomes (1)
Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE)
Proportion of participants with SAE probably or definitely related to study device or device placement procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start24 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture; PelvicStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530497
- Sponsor's protocol ID
- 303203
- Acronym
- REBAR
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
- ClinicalTrials.gov ID
- NCT07530497
- Acronym / sponsor ID
- REBAR / 303203
- Conditions
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction
- Keywords
- Fragility Fracture, pelvic fracture, Osteoporotic pelvic fracture, Fragility Fracture of the pelvis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Apr 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 TORQ TNT for pelvic fragility fractures.
Detailed description
REBAR is a prospective, multicenter, single arm, post-market observational study conducted in a real-world setting on the usage of iFuse TORQ TNT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFP using iFuse TORQ TNT. | – | Device: iFuse TORQ TNT Implant SystemPatients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.
Key inclusion criteria (8 listed)
- ≥ 60 years of age at screening
- Pelvic pain correlating with fracture location that began EITHER within 6 weeks of a known low-energy traumatic event, OR pelvic insufficiency fracture with pain that is limiting mobility
- Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location
- Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT
- Patient and/or patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent
Key exclusion criteria (14 listed)
- Any known anatomic issues that could prevent placement of iFuse TORQ TNT
- Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s)
- Patient requires lumbosacral pelvic fixation as part of index procedure
- Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation or regaining of physical function related to pelvic fracture and is unable to provide a health care proxy to complete study assessments.
- Estimated lifespan < 12 months
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 TORQ TNT Implant SystemFDA-clear implant used for fracture fixation of the pelvis, including acute, non-acute, and non-traumatic fractures and sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. | Device | FFP using iFuse TORQ TNT. |
Primary outcome
Composite Measure
Time frame: 6-months
The participant is considered a success if all of the following apply: * No breakage of study device on any radiographic study * No detectable migration or backout of study device compared to immediate postop or end-of-procedure view * No revision surgery related to the study device
1 secondary outcome
Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE)
Time frame: 12 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 2 Nov 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture; Pelvic and Insufficiency Fractures, run by SI-BONE, Inc. at 3 sites in United States.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Measure (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 2 Nov 2026.