NCT01078480.

Trial name or title	Conservative treatment versus plate osteosynthesis using angular stabile screws and pre‐contoured plates in displaced mid‐shaft clavicular fractures. A prospective randomised multi‐centre study
Methods	Study design: parallel RCT Random sequence generation: not reported Allocation concealment: not reported Masking: single‐blind (outcome assessor)
Participants	Location: Northern Orthopaedic Division, Denmark Target sample size (N): 140 participants Inclusion criteria Age 18‐60 years Fracture located to the middle third of clavicle, where there is no contact between the fractured surface of the main fragments on X‐ray in 1 or 2 of 2 levels Exclusion criteria Bilateral fracture Imminent skin perforation Open fracture Associated neurovascular effect Unstable fracture of neck of scapula "floating shoulder" Fracture of coincidental upper extremity distal for the shoulder Pathological fracture Patient states that there was a unilateral or bilateral shoulder problem before the fracture Fracture realised > 14 days after it arose Circumstances that make it impossible to carry out 1 of the 2 regimes, e.g. mental illness and abuse Circumstances that make follow‐up impossible, e.g. address far from the including departments and staying abroad for a long duration Medical contraindication against surgery or general anaesthesia Former participation in the trial Former fracture contra/ipsilateral at the age of ≥ 15
Interventions	Type of surgical intervention: open reduction and internal fixation with a pre‐contoured titanium plate and screws Type of conservative intervention: sling
Outcomes	Primary outcomes Function or disability measured by Constant score; DASH score used to evaluate the functional score at 6 weeks, 3 months, 6 months and 12 months Timing of outcomes measurement: time frame: 12‐month follow‐up
Starting date	Main ID: NCT01078480. Date of registration: 27 February 2010 Last refreshed on: 21 January 2016 Date of 1stenrolment: April 2010 Status: completed Estimated Study Completion date: December 2015
Contact information	Name: Carsten Moss Jensen, MD Address: not reported Telephone: not reported Email: cmj@rn.dk Affiliation: Orthopaedic Division, North Denmark Region, Aalborg Hospital－Aarhus University Hospital, Denmark
Notes	This trial was published in November 2018, during editorial processing of the review; reference in additional references: Qvist 2018)