Displaced midshaft fractures of the clavicle: non-operative treatment versus Synthes ® plate fixation. A multi-centre randomised controlled trial in the Netherlands.
- Conditions
- clavicle fracturecollarbone fracture10005959
- Registration Number
- NL-OMON34221
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
Completely displaced midshaft fracture of clavicle (Robinson class 2B1 or 2B2). Age between 18and 60 years .No medical contra indications to general anaesthesia. Signed informed consent
Age less than 18 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 radiological consolidation </p><br>
- Secondary Outcome Measures
Name Time Method <p>Complete recovery of function of the shoulder to the level of mobility prior to<br /><br>fracture.<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>