Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device
NCT ID: NCT04163224
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-04-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Sun
Role: STUDY_DIRECTOR
Zimmer Biomet
References
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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.
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.
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.
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.
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. Taxonomy of multiple rib fractures: Results of the chest wall injury society international consensus survey. J Trauma Acute Care Surg. 2020 Feb;88(2):e40-e45. doi: 10.1097/TA.0000000000002282. No abstract available.
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.
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. No abstract available.
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.
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: 10.1016/j.amjsurg.2015.08.008. Epub 2015 Sep 18.
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.2012.12.024. Epub 2013 Feb 13.
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.
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 Trauma Acute Care Surg. 2016 Feb;80(2):187-94. doi: 10.1097/TA.0000000000000925.
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 practice guidelines. Injury. 2017 Feb;48(2):307-321. doi: 10.1016/j.injury.2016.11.026. Epub 2016 Nov 27. No abstract available.
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.
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.
Other Identifiers
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0719-2
Identifier Type: -
Identifier Source: org_study_id
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