RibFix Advantage™ Post-Market Follow-Up | NCT05179005

Studies
RibFix Advantage™ Post-Market Follow-Up

NCT05179005

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Jan 29, 2024Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Rib Fractures

Interventions

RibFix Advantage

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor Terminated

Expanded Access Info

Start Date

Apr 20, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Jan 4, 2022

First Posted Date

Jan 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2024

Last Update Posted Date

Jan 29, 2024Actual

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
RibFix Advantage		Underwent surgical stabilization of rib fractures	Device: RibFix Advantage

Name	Type	Description	Arm Group Labels	Other Names
RibFix Advantage	Device	Intrathoracic rib fracture stabilization	RibFix Advantage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of re-operation	Number of subjects who needed surgical re-intervention related to rib fracture repair	3 months post-op

Secondary Outcomes

Measure	Description	Time Frame
Length of stay in hospital	Time spent in hospital following surgery	Day 0 (surgery) to Day 7

Other Outcomes

Measure	Description	Time Frame
Overall quality of life	American Chronic Pain Association Quality of Life scale	Before surgery and 3 months post-op
Respiratory-related quality of life	Chronic Pulmonary Disease Assessment Test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Christopher W Towe, MD	UH Seidman Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCI Health Surgery Services		Orange	California	92868	United States
University Hospitals Cleveland Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11956391	Background	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.
17670487	Background

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D013898	Thoracic Injuries