Treatment of midshaft clavicle fractures: plate fixation versus figure-of-eight bandage.

Completed

Conditions: Clavicle fractures
Injury, Occupational Diseases, Poisoning
Fracture of shoulder and upper arm

Registration Number: ISRCTN66495030

Lead Sponsor: niversidade Federal de Sao Paulo (UNIFESP) (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Adults age 18-60
2. Patients with completely displaced middle third clavicle fractures, amenable to plate fixation with a minimum of three screws in both fragments
Recruitment of participants will take place in emergency centres of two hospitals in Espirito Santo and Sao Paulo, Brazil.

Exclusion Criteria

1. Open fractures
2. Age under 18 or over 60 years
3. Fracture in the proximal or distal clavicle
4. Fracture associated with nerve or tendon injuries
5. Multiple injuries
6. Additional fractures in the same or contra-lateral limb
7. Previous fracture of the injured clavicle
8. Abnormal function of the uninjured side
9. Inflammatory joint disease
10. Cerebrovascular disease or other severe medical illness
11. Inability to give informed consent or to complete questionnaires

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability of Arm Shoulder and Hand (DASH) questionnaire, assessed at 3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
1. Range of movement<br>2. VAS (visual analogue scale)<br>3. Cosmetic appearance, assessed at the end of the follow up period<br>4. Time to consolidation<br>5. Clavicular length or shortening and shift<br>6. Complications / failure of treatment, monitored throughout the follow up period<br>All outcomes will be assessed at 3, 6 and 12 months unless otherwise stated.