Displaced midshaft fractures of the clavicle: non-operative treatment versus Acumed ® plate fixation. A multi-centre randomised controlled trial in the Netherlands.

Displaced midshaft fractures of the clavicle: non-operative treatment versus Acumed ® plate fixation. A multi-centre randomised controlled trial in the Netherlands. - Non-operative treatment vs. locking plate for midshaft clavicle fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34752

Enrollment

350

Registered

2010-06-15

Start date

2010-06-15

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clavicle fracture collarbone fracture

Interventions

nvt

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Completely displaced midshaft fracture of clavicle (Robinson class 2B1 or 2B2) Age between 16 and 60 years No medical contra indications to general anaesthesia Signed informed consent

Exclusion criteria

Exclusion criteria: Age less than 16 years or older than 60 years A fracture in the proximal or distal third of the clavicle A pathologic fracture (bony abnormalities at the side of the fracture) An open fracture Neurovascular injury with objective neurological findings on physical examination An associated head injury (Glasgow Coma Scale

Design outcomes

Primary

Measure	Time frame
• Complete recovery of function of the shoulder to the level of mobility prior to fracture.	—

Secondary

Measure	Time frame
• Complete radiological consolidation • Complications • Function of the shoulder compared to contra lateral using MicroFET2 ® • Cosmetic aspects • Quality of life, DASH and Constant score	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)