Surgical treatment of midshaft clavicular fractures with dislocation: plate fixation versus intramedullary fixatio

Completed

Conditions: broken collarbone
clavicular fracture
10017322

Registration Number: NL-OMON39026

Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1) Unilateral dislocated midshaft clavicular fracture
2) No medical contraindications to general anesthesia
3) Provided informed consent

Exclusion Criteria

1) Age < 18 years or > 65 years
2) Multitrauma patients
3) Open fracture
4) Pathological fracture
5) Fracture > 1 month old
6) Neurovascular disorders
7) Glasgow Coma Scale <12 (moderate to severe head injury)
8) An inability to comply with follow-up (a transient or an inability to read or complete forms)
9) Pre-existing shoulder pathology in affected side (such as rotator cuff lesion, acromioclavicular pathology or previous shoulder surgery)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>DASH score 6 months after surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>DASH score after one year<br /><br>function of the shoulder (Constant Score) 6 months after surgery<br /><br>DASH and Constant scores at 6 weeks and 3 months<br /><br>complications, both intra-operatively, immediately postoperatively (two weeks),<br /><br>and in a period of 1 year after surgery.<br /><br>the number of re-operations related to unsatisfactory results in a period of<br /><br>one year after surgery<br /><br>time to radiological consolidation<br /><br>perception of pain 2 weeks postoperatively<br /><br>patient satisfaction with the cosmetic result of the treatment 6 months and one<br /><br>year after surgery.<br /><br>elective implant removal in a period of one year after surgery<br /><br><br /><br>Addendum: scapulothoracic rythm one year postoperatively (pilot study)</p><br>