NCT00871468.

Trial name or title	Does anterior‐inferior clavicle plating have a lower rate of soft tissue irritation compared to superior plating? A prospective randomized trial
Methods	Study design: parallel randomised controlled trial Random sequence generation: not reported Allocation concealment: not reported Masking: double‐blind (just before surgery)
Participants	Location: Texas, US Target sample size: 90 participants Inclusion criteria: Active duty, reservists, National Guard service members Completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments) Fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of 3 screws in each proximal and distal fragment) Chronic non‐union and malunion fractures No medical contraindications to general anaesthesia Provided informed consent Exclusion criteria: Aged < 18 or > 65 years Fracture in the proximal or distal third of the clavicle not amenable to plating Pathological fracture Associated head injury (a Glasgow Coma Scale score of < 15 at 21 days after injury) Inability to comply with follow‐up Medical contraindication to surgery or anaesthesia, or both (such as heart disease, renal failure, or active chemotherapy) Lack of consent
Interventions	Intervention 1 (Anterior‐inferior plate): Open reduction and internal fixation with anterior‐inferior plate Intervention 2 (Superior plate): Open reduction and internal fixation with superior plate
Outcomes	Outcomes: function or disability measured by: Constant score and DASH score; adverse events measured by: symptomatic hardware and hardware irritation requiring removal Timing of outcomes measurement: 24 months
Starting date	Main ID: NCT00871468 Date of registration: 26 March 2009 Last refreshed on: 31 March 2014 Date of first enrolment: 1 October 2008 Status: active, not recruiting
Contact information	Name: not reported Address: William Beaumont Army Medical Center ‐ El Paso, TX, US, 79920‐5001 Telephone: not reported Email: not reported Affiliation: William Beaumont Army Medical Center
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