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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05179005
Other study ID # 0719-02
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 20, 2023
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RibFix Advantage
Intrathoracic rib fracture stabilization

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States UCI Health Surgery Services Orange California

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (4)

Campbell 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. — View Citation

Granetzny 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. — View Citation

Nirula 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Overall quality of life American Chronic Pain Association Quality of Life scale Before surgery and 3 months post-op
Other Respiratory-related quality of life Chronic Pulmonary Disease Assessment Test 3 months post-op
Primary Rate of re-operation Number of subjects who needed surgical re-intervention related to rib fracture repair 3 months post-op
Secondary Length of stay in hospital Time spent in hospital following surgery Day 0 (surgery) to Day 7
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Completed NCT04863807 - A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre
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Recruiting NCT03919916 - Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures N/A
Terminated NCT03805360 - The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients Phase 1
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