Zimmer Biomet-RibFix Titan

April 15, 2026 updated by: Zimmer Biomet

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lynsey Boyle
  • Phone Number: (412)552-7111

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent Hospital
        • Contact:
        • Principal Investigator:
          • Nakul Valsangkar, MD
        • Sub-Investigator:
          • Lewis Jacobson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rib Fixation
Consecutive patients will undergo rib fixation procedure using the RibFix Titan fixation system.
Device: The RibFix Titan™ device should be used within this arm of the study.
Rib Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measure (PROMIS-Pain Interference 8a)
Time Frame: 12 Months
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.
12 Months
Patient Reported Outcome Measure (PROMIS-Physical Function 10b)
Time Frame: 12 Months
10-item questionnaire, answered by the patient, with questions asking the patient to rate their level of difficulty performing physical activities.
12 Months
Patient Reported Outcome Measure (Numeric Pain Rating Scale)
Time Frame: 12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Riverpoint Medical

Investigators

  • Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSE2023-20T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on The RibFix Titan™ device should be used within this arm of the study.

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