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| Name | Class |
|---|---|
| Kantonsspital Obwalden | UNKNOWN |
| Spital Schwyz | UNKNOWN |
| Stryker SA | INDUSTRY |
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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?
Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single plating technique | Choice of implant used for single plating left at descretion of treating surgeon. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clavicle plating | Procedure | VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of surgical re-interventions | Any type of re-intervention (i.e. plate removal, screw adjustment etc.) | 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of surgical re-interventions | (including implant removal) | 1 year follow-up |
| Fracture realted infections | According to metsemakers et al, 2018 (Metsemakers WJ, Morgenstern M, McNally et al., 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) |
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Inclusion Criteria:
Generally accepted indications include:
Exclusion Criteria:
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All adult patients (>18 older) presenting at the emergency department (ED) or outpatient clinic with midshaft clavicle fractures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Beeres, PhD/M.D. | Contact | 0041412051914 | frank.beeres@luks.ch | |
| Bryan van de Wall, PhD/M.D. | Contact | 0041412051914 | bryan.vandewall@luks.ch |
| Name | Affiliation | Role |
|---|---|---|
| Frank Beeres, PhD/M.D. | Chefarzt Chirurgie, speziell Unfallchirurgie | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22063756 | Background | 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. | |
| 9619941 | 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. |
| Label | URL |
|---|---|
| Common Terminology Criteria for Adverse Events (CTCAE) | View source |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 2 years follow-up |
| Symptomatic non union | defined as absence of radiological signs of healing (callus formation or fading of fracture lines) combined with pain at the fracture site at 12 months. | 1 year follow-up |
| Asymptomatic non-union | defined as absence of radiological signs of healing (callus formation or fading of fracture lines) without any clinical symptoms. | 1 year follow-up |
| Numbness below scar line | Tested postoperatively and at 12 months follow-up | 1 year follow-up |
| Self-reported implant irritation/implant prominence | According to Hulsman et al, 2018 (17. Hulsmans M, van Heijl M, Houwert R, et al., 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.) | 1 year follow-up |
| Operative time | Baseline |
| Length of surgical incision | Length of surgical incision in cm | basline |
| DASH score | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. | baseline, 3- and 12-monts follow-up |
| EQ-5D | to monitor changes in self-reported health status through time in a given patient group | baseline (pre-injury), 3- and 12-months follow-up |
| VAS pain score | Self-reported pain on a scale of 0 to 10. | 3- and 12-months follow-up |
| VAS for patient satisfaction | Self-reported satisfaction on a scale of 0 to 10 | 3- and 12-months follow-up |
| 22419410 | 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. |
| 26770963 | 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. |
| 22960145 | 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. |
| 31948781 | 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. |
| 32295608 | 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. |
| 35237845 | 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. |
| 28867644 | 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. |
| 30879453 | 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. |
| 12552388 | 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. |
| 37683048 | Derived | 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. |