NCT05579873

Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 336 (estimated)
• Sponsor: Luzerner Kantonsspital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clavicle Fracture

Interventions

Type	Name	Description
PROCEDURE	Clavicle plating	VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2022-10-14
• Last updated: 2022-10-17