Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Clavicle Fracture
• Intervention / Treatment: Procedure: Clavicle 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.

• Study Type: Observational
• Enrollment (Anticipated): 336

Contacts and Locations

• Study Contact: Name: Frank Beeres, PhD/M.D.; Phone Number: 0041412051914; Email: frank.beeres@luks.ch
• Study Contact Backup: Name: Bryan van de Wall, PhD/M.D.; Phone Number: 0041412051914; Email: bryan.vandewall@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single plating technique; Choice of implant used for single plating left at descretion of treating surgeon.	Procedure: 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.	Procedure: Clavicle plating; VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Collaborators: Stryker SA; Kantonsspital Obwalden; Spital Schwyz
• Investigators: Principal Investigator: Frank Beeres, PhD/M.D., Chefarzt Chirurgie, speziell Unfallchirurgie

Publications and helpful links

General Publications

• 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.

Helpful Links

• Common Terminology Criteria for Adverse Events (CTCAE)

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Bone Plates; Clavicle/injuries; Non-Randomized Controlled Trials as Topic
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2022-00574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No