Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

Luzerner Kantonsspital

Status: Not yet enrolling

Conditions: Clavicle Fracture

Treatments: Procedure: Clavicle plating

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05579873

2022-00574

Details and patient eligibility

About

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?

Full 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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

336 participants in 2 patient groups

Single plating technique

Description:

Choice of implant used for single plating left at descretion of treating surgeon.

Treatment:

Procedure: Clavicle plating

Double plating technique

Description:

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.

Treatment:

Procedure: Clavicle plating