New device aims to improve rib fracture repair
NCT ID NCT07485829
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing the safety and performance of the RibFix Titan™ device, used to fix broken ribs or during chest wall surgery. Researchers will follow 54 adults for 90 days after surgery to see how well the device works and if any additional procedures are needed. Participants will also report how their pain and physical function change over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RibFix Titan™ device
- What this could lead to
- If successful, this could confirm that RibFix Titan™ is a safe and effective option for repairing broken ribs, improving recovery and quality of life.
- What could go wrong
- This is a small, single-center study with only 54 participants, so results may not apply to everyone. There is a risk of reoperation or complications from the device.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 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 study population will include subjects with rib fractures identified at the point of clinical presentation, including emergency departments, trauma centers, or outpatient healthcare settings.
- Ages
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18 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. At least 18 years of age 2. Willing and able to sign an Institutional Review Board (IRB) approved Informed Consent Form and able to comply with study requirements, in the Investigator's opinion 3. Independent of study participation, patient qualifies for fixation, stabilization, and/or fusion of rib fractures or osteotomies of normal and osteoporotic bone with the study device Exclusion Criteria: 1. Midline Sternotomy: sternotomy incisions crossing the midline 2. Active Infection: patients should not have any ongoing infections 3. Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation 4. Inability to Adhere to Post-operative Care: Patients must have the ability and willingness to comply with post-operative care instructions, which may not be possible for individuals with certain mental or neurological conditions 5. Patients not expected to survive the duration of follow-up due to the involvement of trauma situations 6. Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women
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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
1 site. 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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Ascension St. Vincent Hospital
RECRUITINGIndianapolis, Indiana, 46260, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Topical gel could ease rib fracture pain in the ER
- Pain relief showdown for broken ribs: IV lidocaine vs nerve block
- Rib fracture surgery: does age matter more than injury severity?
- New study aims to find best painkiller for broken ribs after surgery
- Freezing nerves during rib surgery may cut painkiller use