Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

NCT05579873 | Unknown DMC

• 1 other identifier: 2022-00574
• Study Type: observational
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is: 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?

Conditions

Clavicle Fracture

Keywords

Clavicle/injuries; Bone Plates; Non-Randomized Controlled Trials as Topic

Outcome Measures

Primary Outcomes (1)

• Number of surgical re-interventions

  Any type of re-intervention (i.e. plate removal, screw adjustment etc.)

  2 years follow-up

Secondary Outcomes (12)

• Number of surgical re-interventions

  1 year follow-up

• Fracture realted infections

  2 years follow-up

• Symptomatic non union

  1 year follow-up

• Asymptomatic non-union

  1 year follow-up

• Numbness below scar line

  1 year follow-up

Study Arms (2)

Single plating technique

Choice of implant used for single plating left at descretion of treating surgeon.

Procedure: Clavicle plating

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.

Procedure: Clavicle plating

Interventions

Clavicle plating PROCEDURE

VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate

Double plating technique; Single plating technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients (\>18 older) presenting at the emergency department (ED) or outpatient clinic with midshaft clavicle fractures.

You may qualify if:

• years and older
• 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)

You may not qualify if:

• Delayed presentation (\> 14 days)
• 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)

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Kantonsspital Obwalden: collaborator
• Spital Schwyz: collaborator
• Stryker SA: collaborator

Related Publications (12)

• 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.

  PMID: 22063756 BACKGROUND

• 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.

  PMID: 9619941 BACKGROUND

• 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.

  PMID: 22419410 BACKGROUND

• 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.

  PMID: 26770963 BACKGROUND

• 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.

  PMID: 22960145 BACKGROUND

• 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.

  PMID: 31948781 BACKGROUND

• 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.

  PMID: 32295608 BACKGROUND

• 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.

  PMID: 35237845 BACKGROUND

• 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.

  PMID: 28867644 BACKGROUND

• 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.

  PMID: 30879453 BACKGROUND

• 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.

  PMID: 12552388 BACKGROUND

• 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.

  PMID: 37683048 DERIVED

Related Links

• Common Terminology Criteria for Adverse Events (CTCAE)

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Frank Beeres, PhD/M.D.

  Chefarzt Chirurgie, speziell Unfallchirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Beeres, PhD/M.D.

CONTACT

0041412051914; frank.beeres@luks.ch

Bryan van de Wall, PhD/M.D.

CONTACT

0041412051914; bryan.vandewall@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: November 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 17, 2022

Record last verified: 2022-07