NCT02398006.

Trial name or title	Figure‐of‐eight bandage versus arm sling for treating middle third clavicle fractures in adults: a randomised controlled trial
Methods	Study design: parallel randomised controlled trial Random sequence generation: participants will be randomised according to computer generated randomisation Allocation concealment: by sealed opaque envelope Masking: open label
Participants	Location: São Paulo, Brazil Target sample size: 110 participants Inclusion criteria: Adults aged between 18 and 65 years with middle third clavicle fracture Acute fracture (< 10 days), comprising all types of middle third clavicle fractures (non‐displaced and displaced fractures) No medical contraindication to proposed methods of immobilisation Understanding of Portuguese language and written informed consent Exclusion criteria: Pathological fracture Open fracture Neurovascular injury on physical examination Associated head injury (Glasgow Coma Scale score < 12),·Ipsilateral upper limb fractures and/or dislocation (except hand and fingers) History of frozen shoulder Previous disease in the limb that could influence the results (e.g. rheumatoid arthritis),· Inability to comply with follow‐up (inability to read or complete forms)
Interventions	Intervention 1: figure‐of‐eight bandage Intervention 2: arm sling
Outcomes	Outcomes: function or disability measured by: DASH questionnaire and UCLA score; pain measured by VAS; failure of treatment; adverse events measured by: a) cosmetic results: perception of deformity or asymmetry (dichotomous data); b) asymptomatic nonunion (i.e. the fracture has not radiographically healed, although pain is absent); c) stiffness/restriction of the shoulder movement (compared with contralateral side); and numbers returning to previous activities Timing of outcomes measurement: 12 months
Starting date	Main ID: NCT02398006 Date of registration: 12 March 2015 Last refreshed on: 19 March 2015 Date of first enrolment: January 2016 Status: recruiting
Contact information	Name: Dr Mario Lenza Address: Hospital Israelita Albert Einstein – Avenida Albert Einstein, 627/701 – Jardim Leonor – CEP: 05652‐900 – São Paulo, SP, Brazil Telephone: 55 11 21511444 Email: mario.lenza@einstein.br Affiliation: Hospital Israelita Albert Einstein
Notes	A published protocol for this trial is available (Lenza 2016)

DASH: Disability of the Arm, Shoulder and Hand questionnaire
 UCLA: University of California, Los Angeles
 VAS: visual analog score