Clavicle fractures Injury, Occupational Diseases, Poisoning Fracture of shoulder and upper arm
Conditions
Interventions
Patients will be randomised to
1. The surgical group (plate fixation):
All participants will be undergo the operation within two weeks after the injury
prophylactic antibiotics will be used. Under a general anaesthetic, the patient will be positioned in a beach-chair semi-sitting position. The involved shoulder will be prepared and draped, and an obl
Sponsors
Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability of Arm Shoulder and Hand (DASH) questionnaire, assessed at 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Range of movement 2. VAS (visual analogue scale) 3. Cosmetic appearance, assessed at the end of the follow up period 4. Time to consolidation 5. Clavicular length or shortening and shift 6. Complications / failure of treatment, monitored throughout the follow up period All outcomes will be assessed at 3, 6 and 12 months unless otherwise stated. | — |
Countries
Brazil
Outcome results
None listed