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.
Study Type
OBSERVATIONAL
Enrollment
336
VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate
Number of surgical re-interventions
Any type of re-intervention (i.e. plate removal, screw adjustment etc.)
Time frame: 2 years follow-up
Number of surgical re-interventions
(including implant removal)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 1 year follow-up
Numbness below scar line
Tested postoperatively and at 12 months follow-up
Time frame: 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.)
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Time frame: 1 year follow-up
Operative time
Time frame: Baseline
Length of surgical incision
Length of surgical incision in cm
Time frame: 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.
Time frame: baseline, 3- and 12-monts follow-up
EQ-5D
to monitor changes in self-reported health status through time in a given patient group
Time frame: baseline (pre-injury), 3- and 12-months follow-up
VAS pain score
Self-reported pain on a scale of 0 to 10.
Time frame: 3- and 12-months follow-up
VAS for patient satisfaction
Self-reported satisfaction on a scale of 0 to 10
Time frame: 3- and 12-months follow-up