New pelvic implant aims to help seniors heal faster
NCT ID NCT07530497
First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 4 times
Summary
This study will follow 120 adults aged 60 and older who have a pelvic fracture and are scheduled to receive the iFuse TORQ TNT implant, a screw-like device that stabilizes the pelvis. Researchers will check if the device stays in place, doesn't break, and doesn't require additional surgery. The goal is to see how well this implant works in real-world settings for treating pelvic fractures caused by falls or bone weakness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iFuse TORQ TNT implant (a metal screw-like device to stabilize pelvic fractures)
- What this could lead to
- If successful, this could show that the iFuse TORQ TNT implant is a safe and effective option for fixing pelvic fractures in older adults, potentially reducing pain and improving mobility.
- What could go wrong
- This is an early real-world study with no control group, so results may not prove the implant is better than other treatments. Risks include device breakage, migration, or need for revision surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 60 years of age at screening 2. 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 3. Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location 4. Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT 5. Patient and/or patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent 6. Patient agrees to comply with study schedule of assessments 7. Patient and/or patient's proxy can complete study-related surveys 8. Patient was able to ambulate prior to index fracture Exclusion Criteria: 1. Any known anatomic issues that could prevent placement of iFuse TORQ TNT 2. Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s) 3. Patient requires lumbosacral pelvic fixation as part of index procedure 4. 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. 5. Estimated lifespan \< 12 months 6. Presence of tumor, lytic lesion, infection, or soft tissues that precludes safe internal fixation 7. Not candidate for surgery due to underlying medical illness 8. Social situation that makes 12-month follow-up unlikely 9. History of recent (within 1 year) non-index pelvic fracture with non-union 10. Other clinically active fragility fracture of spine, hip or arms/legs that could impair recovery from sacral fracture 11. Known allergy to titanium or titanium alloys 12. Known or suspected active drug or alcohol abuse, including opioids 13. Patient is a prisoner or ward of the state 14. Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Orthopaedic Associates of Reading
RECRUITINGWyomissing, Pennsylvania, 19610, United States
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