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

Completed

• Conditions: clavicle fracture; collarbone fracture; 10017322

• Registration Number: NL-OMON34752
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 350

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

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 <12)
An upper extremity fracture distal to the shoulder
A fracture seen more than 14 days after injury
Inability to give informed consent with the randomisation procedure
A medical contra-indication to surgery/ anaesthesia (such as a heart disease, kidney failure or active chemotherapy)
Inability to comply with follow-up
Prior surgery to the shoulder
Prior shoulder complaints

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Complete recovery of function of the shoulder to the level of mobility prior<br /><br>to fracture.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Complete radiological consolidation<br /><br>• Complications<br /><br>• Function of the shoulder compared to contra lateral using MicroFET2 ®<br /><br>• Cosmetic aspects<br /><br>• Quality of life, DASH and Constant score </p><br>