Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

Conditions
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Clavicle Fracture

Intervention / Treatment
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* Procedure: Clavicle plating


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single plating technique<br>Choice of implant used for single plating left at descretion of treating surgeon. | Procedure: Clavicle plating<br>* VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate<br>|
| Double plating technique<br>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<br>* VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clavicle/injuries, Bone Plates, Non-Randomized Controlled Trials as Topic