Rib FracturesZB-PIONEERNCT05179005
RibFix Advantage™ Post-Market Follow-Up
An observational study of Rib Fractures, run by Zimmer Biomet at 2 sites in United States.
Trial summary
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- RibFix Advantage
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thoracic trauma comprises 20-25% of all traumas worldwide and constitutes the third most common cause of death after abdominal injury and head trauma in polytrauma patients. Thoracic trauma directly accounts for approximately 25% of trauma-related mortality and is a contributing factor in another 25% of such cases. The incidence of rib fractures due to trauma has been reported by various studies to range between 7 and 40%. There is no standard treatment for rib fractures, though there are several options. Failure to treat rib fracture pain can lead to reduced movement, cough suppression, and secondary infection. The conservative option for caring for a rib fracture involves the non-operative management of pain.
Who may be able to join
- 18-80 years of age, male or female
- Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
- Minimum amount of follow-up data available, including one visit post-surgery
- Willing and able to sign an Informed Consent for research
- Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery
Who cannot join
- Latent or active infection with positive culture at the time of implantation
- Documented history of metal sensitivity
- Documented psychiatric condition preventing the patient from following post-op care instructions
- Fixation of the first and/or second (true) vertebrosternal rib
- Bilateral rib fractures
- Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization
- Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonary contusion requiring mechanical ventilation)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UCI Health Surgery Services
Orange, California, 92868
About this study
Official title: Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone
Read the detailed description
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021
- Conditions
- Rib Fractures
- Being tested
- RibFix Advantage
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibFix AdvantageDevice
Intrathoracic rib fracture stabilization
| Study group | Role | What they receive |
|---|---|---|
| RibFix Advantage | Underwent surgical stabilization of rib fractures Receives: Device: RibFix Advantage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-operation
Number of subjects who needed surgical re-intervention related to rib fracture repair
Measured: 3 months post-op
Secondary outcomes (1)
Length of stay in hospital
Time spent in hospital following surgery
Measured: Day 0 (surgery) to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start20 Apr 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Sponsor Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher W Towe, MD, Principal investigator, UH Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179005
- Sponsor's protocol ID
- 0719-02
- Acronym
- ZB-PIONEER
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
PubMed 11956391Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
PubMed 17670487Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.
PubMed 16676852Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps--techniques and quality of life follow-up. J Trauma. 2009 Sep;67(3):596-601. doi: 10.1097/TA.0b013e3181ad8cb7.
PubMed 19741406
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
- ClinicalTrials.gov ID
- NCT05179005
- Acronym / sponsor ID
- ZB-PIONEER / 0719-02
- Conditions
- Rib Fractures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Jan 2022 (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.
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone
Detailed description
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RibFix Advantage | – | Device: RibFix AdvantageUnderwent surgical stabilization of rib fractures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic trauma comprises 20-25% of all traumas worldwide and constitutes the third most common cause of death after abdominal injury and head trauma in polytrauma patients. Thoracic trauma directly accounts for approximately 25% of trauma-related mortality and is a contributing factor in another 25% of such cases. The incidence of rib fractures due to trauma has been reported by various studies to range between 7 and 40%. There is no standard treatment for rib fractures, though there are several options. Failure to treat rib fracture pain can lead to reduced movement, cough suppression, and secondary infection. The conservative option for caring for a rib fracture involves the non-operative management of pain.
Key inclusion criteria (5 listed)
- 18-80 years of age, male or female
- Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
- Minimum amount of follow-up data available, including one visit post-surgery
- Willing and able to sign an Informed Consent for research
- Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery
Key exclusion criteria (7 listed)
- Latent or active infection with positive culture at the time of implantation
- Documented history of metal sensitivity
- Documented psychiatric condition preventing the patient from following post-op care instructions
- Fixation of the first and/or second (true) vertebrosternal rib
- Bilateral rib fractures
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 |
|---|---|---|
| RibFix AdvantageIntrathoracic rib fracture stabilization | Device | RibFix Advantage |
Primary outcome
Rate of re-operation
Time frame: 3 months post-op
Number of subjects who needed surgical re-intervention related to rib fracture repair
1 secondary outcome
Length of stay in hospital
Time frame: Day 0 (surgery) to Day 7
Results and safety
The study was stopped early (reason given: Sponsor Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 11956391Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
- Background: PubMed 17670487Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
- Background: PubMed 16676852Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.
- Background: PubMed 19741406Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps--techniques and quality of life follow-up. J Trauma. 2009 Sep;67(3):596-601. doi: 10.1097/TA.0b013e3181ad8cb7.
- Rib Trauma SolutionsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christopher W Towe, MD principal investigator
UH Seidman Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures, run by Zimmer Biomet at 2 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: Sponsor Terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-operation (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179005, which also lists 4 linked publications.
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 29 Jan 2024.