Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
NCT ID: NCT05579873
Last Updated: 2022-10-17
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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UNKNOWN
336 participants
OBSERVATIONAL
2022-11-01
2025-10-01
Brief Summary
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1\. Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single plating technique
Choice of implant used for single plating left at descretion of treating surgeon.
Clavicle plating
VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate
Double plating technique
Double plating consist of one VariAx 2.0mm plate positioned on the superior aspect of the clavicula and a second VariAx 2.4mm or 2.7 mm on the anterior side. Use of this implant will be according to the device's cleared indications of use.
Clavicle plating
VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate
Interventions
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Clavicle plating
VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate
Eligibility Criteria
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Inclusion Criteria
* Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2)
* Patients that are eligible for operative treatment of clavicle fractures.
Generally accepted indications include:
* Displacement of one or more shaft width
* Shortening of more than 1cm in length
* High demand patients (physical activity)
Exclusion Criteria
* Initial operative treatment at non-participating hospitals
* Open fractures
* Pathological fractures
* Re-fractures of clavicle
* Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs)
* Cognitive impairment or language barrier precluding answering questionnaires
* Unable to complete follow-up (e.g. different residential area/tourists)
18 Years
ALL
No
Sponsors
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Kantonsspital Obwalden
UNKNOWN
Spital Schwyz
UNKNOWN
Stryker SA
INDUSTRY
Luzerner Kantonsspital
OTHER
Responsible Party
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Principal Investigators
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Frank Beeres, PhD/M.D.
Role: PRINCIPAL_INVESTIGATOR
Chefarzt Chirurgie, speziell Unfallchirurgie
Central Contacts
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References
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van der Meijden OA, Gaskill TR, Millett PJ. Treatment of clavicle fractures: current concepts review. J Shoulder Elbow Surg. 2012 Mar;21(3):423-9. doi: 10.1016/j.jse.2011.08.053. Epub 2011 Nov 6.
Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br. 1998 May;80(3):476-84. doi: 10.1302/0301-620x.80b3.8079.
McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. J Bone Joint Surg Am. 2012 Apr 18;94(8):675-84. doi: 10.2106/JBJS.J.01364.
Devji T, Kleinlugtenbelt Y, Evaniew N, Ristevski B, Khoudigian S, Bhandari M. Operative versus nonoperative interventions for common fractures of the clavicle: a meta-analysis of randomized controlled trials. CMAJ Open. 2015 Nov 10;3(4):E396-405. doi: 10.9778/cmajo.20140130. eCollection 2015 Oct-Dec.
Althausen PL, Shannon S, Lu M, O'Mara TJ, Bray TJ. Clinical and financial comparison of operative and nonoperative treatment of displaced clavicle fractures. J Shoulder Elbow Surg. 2013 May;22(5):608-11. doi: 10.1016/j.jse.2012.06.006. Epub 2012 Sep 7.
Chen MJ, DeBaun MR, Salazar BP, Lai C, Bishop JA, Gardner MJ. Safety and efficacy of using 2.4/2.4 mm and 2.0/2.4 mm dual mini-fragment plate combinations for fixation of displaced diaphyseal clavicle fractures. Injury. 2020 Mar;51(3):647-650. doi: 10.1016/j.injury.2020.01.014. Epub 2020 Jan 9.
Zhang F, Chen F, Qi Y, Qian Z, Ni S, Zhong Z, Zhang X, Li D, Yu B. Finite element analysis of dual small plate fixation and single plate fixation for treatment of midshaft clavicle fractures. J Orthop Surg Res. 2020 Apr 15;15(1):148. doi: 10.1186/s13018-020-01666-x.
Rompen IF, van de Wall BJM, van Heijl M, Bunter I, Diwersi N, Tillmann F, Migliorini F, Link BC, Knobe M, Babst R, Beeres FJP. Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3063-3071. doi: 10.1007/s00068-021-01845-3. Epub 2022 Mar 2.
Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24.
Hulsmans M, van Heijl M, Houwert R, Verleisdonk EJ, Frima H. Intramedullary nailing of displaced midshaft clavicle fractures using a TEN with end cap: issues encountered. Acta Orthop Belg. 2018 Dec;84(4):479-484.
Germann G, Harth A, Wind G, Demir E. [Standardisation and validation of the German version 2.0 of the Disability of Arm, Shoulder,Hand (DASH) questionnaire]. Unfallchirurg. 2003 Jan;106(1):13-9. doi: 10.1007/s00113-002-0456-x. German.
Lecoultre Y, van de Wall BJM, Diwersi N, Pfarr SW, Galliker B, Babst R, Link BC, Beeres FJP. A natural experiment study: Low-profile double plating versus single plating techniques in midshaft clavicle fractures-Study protocol. PLoS One. 2023 Sep 8;18(9):e0291238. doi: 10.1371/journal.pone.0291238. eCollection 2023.
Related Links
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Common Terminology Criteria for Adverse Events (CTCAE)
Other Identifiers
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2022-00574
Identifier Type: -
Identifier Source: org_study_id
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