Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device

Rib Fracture Multiple Clinical Trial

— RF-Advantage  

Official title:

Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device. Case Series

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04163224
• Other study ID #: 0719-2
• Status: Withdrawn
• Start date: April 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective review of demographics and adverse events from cases completed with the RibFix Advantage System. Evaluation of device integrity, and performance by a prospective CT scan with a minimum of 3 months post-implantation.

Description:

The RibFix Advantage System is a novel intrathoracic titanium plating system that is FDA-cleared for the treatment of rib fractures. The RibFix Advantage System is designed to be implanted in a less invasive procedure where plates are introduced and placed on the pleural cortex of the rib during video-assisted thoracoscopic surgery. Intrathoracic plate placement allows for smaller cutaneous incisions and less muscle disruption, which may aid in patient recovery compared to traditional open reduction internal fixation systems that are currently available.

The purpose of this study is to gather the first clinical data on this novel device in the context of a case series of patients with radiologic and quality-of-life follow-up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female

• = 18 years old (no upper limit)

• Underwent surgical repair of rib fracture(s) with the RibFix Advantage System alone or in combination with other systems for fracture repair

• Signed Informed Consent Form for participation in a clinical trial

• Willing and able to return for a follow-up visit (includes a computed tomography (CT) scan of the chest)

Exclusion Criteria:

• Off label use of RibFix Advantage (e.g., active or latent infection at the time of implantation, sepsis, metal sensitivity)

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures

Intervention

Device:
• RibFix Advantage
Class II device in the United States; consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys. When fully assembled, the bridge plate is placed on the underside of the rib (pleural cortex); the threaded locking posts extend through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior (cutaneous) side of the rib. The combined threaded locking post and cap provides for fixation of the bridge and stabilization of the fracture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

References & Publications (15)

Edwards JG, Clarke P, Pieracci FM, Bemelman M, Black EA, Doben A, Gasparri M, Gross R, Jun W, Long WB, Lottenberg L, Majercik S, Marasco S, Mayberry J, Sarani B, Schulz-Drost S, Van Boerum D, Whitbeck S, White T; Chest Wall Injury Society collaborators. T — 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. Epub 2005 Sep 15. — View Citation

Leinicke JA, Elmore L, Freeman BD, Colditz GA. Operative management of rib fractures in the setting of flail chest: a systematic review and meta-analysis. Ann Surg. 2013 Dec;258(6):914-21. doi: 10.1097/SLA.0b013e3182895bb0. Review. — View Citation

Majercik S, Cannon Q, Granger SR, Van Boerum DH, White TW. Regarding: Long-term patient outcomes after surgical stabilization of rib fractures. Am J Surg. 2015 Jul;210(1):199-200. doi: 10.1016/j.amjsurg.2015.03.020. Epub 2015 May 21. — View Citation

Majercik S, Cannon Q, Granger SR, VanBoerum DH, White TW. Long-term patient outcomes after surgical stabilization of rib fractures. Am J Surg. 2014 Jul;208(1):88-92. doi: 10.1016/j.amjsurg.2013.08.051. Epub 2014 Jan 4. — View Citation

Majercik S, Vijayakumar S, Olsen G, Wilson E, Gardner S, Granger SR, Van Boerum DH, White TW. Surgical stabilization of severe rib fractures decreases incidence of retained hemothorax and empyema. Am J Surg. 2015 Dec;210(6):1112-6; discussion 1116-7. doi: — View Citation

Majercik S, Wilson E, Gardner S, Granger S, VanBoerum DH, White TW. In-hospital outcomes and costs of surgical stabilization versus nonoperative management of severe rib fractures. J Trauma Acute Care Surg. 2015 Oct;79(4):533-8; discussion 538-9. doi: 10.1097/TA.0000000000000820. — View Citation

Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.20 — View Citation

Pieracci FM, Agarwal S, Doben A, Shiroff A, Lottenberg L, Whitbeck SA, White TW. Indications for surgical stabilization of rib fractures in patients without flail chest: surveyed opinions of members of the Chest Wall Injury Society. Int Orthop. 2018 Feb;42(2):401-408. doi: 10.1007/s00264-017-3612-1. Epub 2017 Aug 29. — View Citation

Pieracci FM, Lin Y, Rodil M, Synder M, Herbert B, Tran DK, Stoval RT, Johnson JL, Biffl WL, Barnett CC, Cothren-Burlew C, Fox C, Jurkovich GJ, Moore EE. A prospective, controlled clinical evaluation of surgical stabilization of severe rib fractures. J Tra — View Citation

Pieracci FM, Majercik S, Ali-Osman F, Ang D, Doben A, Edwards JG, French B, Gasparri M, Marasco S, Minshall C, Sarani B, Tisol W, VanBoerum DH, White TW. Consensus statement: Surgical stabilization of rib fractures rib fracture colloquium clinical practic — View Citation

Pieracci FM. Completely thoracoscopic surgical stabilization of rib fractures: can it be done and is it worth it? J Thorac Dis. 2019 May;11(Suppl 8):S1061-S1069. doi: 10.21037/jtd.2019.01.70. Review. — View Citation

Sarani B, Allen R, Pieracci FM, Doben AR, Eriksson E, Bauman ZM, Gupta P, Semon G, Greiffenstein P, Chapman AJ, Kim BD, Lottenberg L, Gardner S, Marasco S, White T. Characteristics of hardware failure in patients undergoing surgical stabilization of rib fractures: A Chest Wall Injury Society multicenter study. J Trauma Acute Care Surg. 2019 Dec;87(6):1277-1281. doi: 10.1097/TA.0000000000002373. — View Citation

Slobogean GP, MacPherson CA, Sun T, Pelletier ME, Hameed SM. Surgical fixation vs nonoperative management of flail chest: a meta-analysis. J Am Coll Surg. 2013 Feb;216(2):302-11.e1. doi: 10.1016/j.jamcollsurg.2012.10.010. Epub 2012 Dec 5. — 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; discussio — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture stability	Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap	3 months post-implantation
Primary	Device integrity	Evaluated by a computed tomography (CT) scan. Images should demonstrate no plate migration, no post/cap migration and no plate fracture	3 months post-implantation
Secondary	Adverse Events of Interest	Includes: Chest infections, Empyema, Mediastinitis. Wound infection, Wound dehiscence, Chest wall deformity related to the device, Pleural effusion related to the device, Hemothorax related to the device, Pneumothorax related to the device and Hemo-pneumothorax related to the device	From the the date of implantation until the day of hospital discharge, or up to 10 days post-implantation, whichever occurs first; 30 days post surgery; 3 month post-implantation