Clinical trial NCT05579873: Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
Official title: Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clavicle Fracture
Keywords: Clavicle/injuries
Bone Plates
Non-Randomized Controlled Trials as Topic
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Kantonsspital Obwalden
name: Spital Schwyz
name: Stryker SA
First posted: 2022-10-14
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of surgical re-interventions
timeFrame: 2 years follow-up
Secondary outcomes:
measure: Number of surgical re-interventions
timeFrame: 1 year follow-up
measure: Fracture realted infections
timeFrame: 2 years follow-up
measure: Symptomatic non union
timeFrame: 1 year follow-up
measure: Asymptomatic non-union
timeFrame: 1 year follow-up
measure: Numbness below scar line
timeFrame: 1 year follow-up
measure: Self-reported implant irritation/implant prominence
timeFrame: 1 year follow-up
measure: Operative time
timeFrame: Baseline
measure: Length of surgical incision
timeFrame: basline
measure: DASH score
timeFrame: baseline, 3- and 12-monts follow-up
measure: EQ-5D
timeFrame: baseline (pre-injury), 3- and 12-months follow-up
measure: VAS pain score
timeFrame: 3- and 12-months follow-up
measure: VAS for patient satisfaction
timeFrame: 3- and 12-months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Chefarzt Chirurgie, speziell Unfallchirurgie
name: Frank Beeres, PhD/M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.