Rib FractureNCT07485829
Zimmer Biomet-RibFix Titan
An observational study of Rib Fracture and Rib Fracture Multiple, run by Zimmer Biomet at 1 site in United States.
Trial summary
Prospective, single-center, non-randomized, single-cohort, post-market clinical follow-up study to confirm the safety, performance, and clinical benefits for the use of the RibFix Titan™ system implants and instrumentation) in the fusion, stabilization, and fixation of fractures in the chest wall including rib… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture, Rib Fracture Multiple
- What is being tested?
- The RibFix Titan™ device should be used within this arm of the study.
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Mar 2028
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- At least 18 years of age
- 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
- 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
Who cannot join
- Midline Sternotomy: sternotomy incisions crossing the midline
- Active Infection: patients should not have any ongoing infections
- Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation
- 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
- Patients not expected to survive the duration of follow-up due to the involvement of trauma situations
- Patients with a history of alcohol or substance abuse, as well as vulnerable populations such as prisoners and pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lynsey Boyle contact
United States1 site, 1 recruiting
- Recruiting
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260
Jamie Williams, 317-210-3487, jamie.williams4@ascension.org
Nakul Valsangkar, MD
About this study
Official title: Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™
Prospective, single-center, non-randomized, single-cohort, post-market clinical follow-up study to confirm the safety, performance, and clinical benefits for the use of the RibFix Titan™ system implants and instrumentation) in the fusion, stabilization, and fixation of fractures in the chest wall including rib reconstructive surgical procedures, trauma, or planned osteotomies.
Read the detailed description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.
The primary objective is the assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.
This study is designed to evaluate safety parameters by recording the incidence and frequency of complications and adverse events. Relationship of the events to the implant, instrumentation, and/or procedure through the operative and post-operative follow-up periods shall be specified.
The secondary objectives include functional performance and clinical benefits by clinical evaluation of fracture/osteotomy union and patient reported outcome measures (PROMs). This study will also measure resource utilization in subjects with RibFix Titan™, including intensive care unit (ICU) length of stay, hospital length of stay, and operative time.
Data collection will occur at the following intervals: Pre-operative, Operative, 14-days, 45-days, 90-days, and 1-year post-operatively. Enrollment for the study is anticipated to last approximately 12 months. Allowing for 12 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 24 months.
- Conditions
- Rib Fracture, Rib Fracture Multiple
- Being tested
- The RibFix Titan™ device should be used within this arm of the study.
- Keywords
- RibFix Titan
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The RibFix Titan™ device should be used within this arm of the study.Device
Rib Fixation
| Study group | Role | What they receive |
|---|---|---|
| Rib Fixation | Consecutive patients will undergo rib fixation procedure using the RibFix Titan fixation system. Receives: Device: The RibFix Titan™ device should be used within this arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Patient Safety
Assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.
Measured: 90 days
Secondary outcomes (3)
Patient Reported Outcome Measure (PROMIS-Pain Interference 8a)
8-item questionnaire, completed by the patient, with questions asking the patient to rate how much pain has impacted daily functioning over the past 7 days.
Measured: 12 Months
Patient Reported Outcome Measure (PROMIS-Physical Function 10b)
10-item questionnaire, answered by the patient, with questions asking the patient to rate their level of difficulty performing physical activities.
Measured: 12 Months
Patient Reported Outcome Measure (Numeric Pain Rating Scale)
1-item questionnaire asking the patient to rate their pain on average on a numeric scale, from 0 to 10 where 0 is No Pain and 10 is Worst Imaginable Pain.
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 posted20 Mar 2026
- Study start31 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Riverpoint Medical
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485829
- Sponsor's protocol ID
- CSE2023-20T
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimmer Biomet Patient Outcomes and Experience After Chest Wall Repair With RibFix Titan™
- ClinicalTrials.gov ID
- NCT07485829
- Acronym / sponsor ID
- CSE2023-20T
- Conditions
- Rib Fracture, Rib Fracture Multiple
- Keywords
- RibFix Titan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Riverpoint Medical
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Mar 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.
Prospective, single-center, non-randomized, single-cohort, post-market clinical follow-up study to confirm the safety, performance, and clinical benefits for the use of the RibFix Titan™ system implants and instrumentation) in the fusion, stabilization, and fixation of fractures in the chest wall including rib reconstructive surgical procedures, trauma, or planned osteotomies.
Detailed description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.
The primary objective is the assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.
This study is designed to evaluate safety parameters by recording the incidence and frequency of complications and adverse events. Relationship of the events to the implant, instrumentation, and/or procedure through the operative and post-operative follow-up periods shall be specified.
The secondary objectives include functional performance and clinical benefits by clinical evaluation of fracture/osteotomy union and patient reported outcome measures (PROMs). This study will also measure resource utilization in subjects with RibFix Titan™, including intensive care unit (ICU) length of stay, hospital length of stay, and operative time.
Data collection will occur at the following intervals: Pre-operative, Operative, 14-days, 45-days, 90-days, and 1-year post-operatively. Enrollment for the study is anticipated to last approximately 12 months. Allowing for 12 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rib Fixation | – | Device: The RibFix Titan™ device should be used within this arm of the study.Consecutive patients will undergo rib fixation procedure using the RibFix Titan fixation system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- At least 18 years of age
- 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
- 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
Key exclusion criteria (6 listed)
- Midline Sternotomy: sternotomy incisions crossing the midline
- Active Infection: patients should not have any ongoing infections
- Material Sensitivity: where sensitivity to materials is suspected, comprehensive testing should be conducted before implantation
- 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
- Patients not expected to survive the duration of follow-up due to the involvement of trauma situations
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 |
|---|---|---|
| The RibFix Titan™ device should be used within this arm of the study.Rib Fixation | Device | Rib Fixation |
Primary outcome
Evaluation of Patient Safety
Time frame: 90 days
Assessment of safety by analyzing reoperation rates related to the RibFix Titan™ at 90 days post-implantation. A reoperation will be considered any additional surgical procedure to revise, adjust, or replace the subject device's components and/or any surgical procedure to manage complications directly caused by the device.
3 secondary outcomes
Patient Reported Outcome Measure (PROMIS-Pain Interference 8a)
Time frame: 12 Months
Patient Reported Outcome Measure (PROMIS-Physical Function 10b)
Time frame: 12 Months
Patient Reported Outcome Measure (Numeric Pain Rating Scale)
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 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Rib Fracture
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
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.
Lynsey Boyle contact
Hillary Overholser study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fracture and Rib Fracture Multiple, run by Zimmer Biomet at 1 site 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 3 inclusion and 6 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Megan McKinnie ((919)381-7091, megan.mckinnie@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Patient Safety (time frame: 90 days). 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 21 Apr 2026.