NCT00999193.

Study name	Proximal humeral comminuted fractures in the elderly ‐ PERCELE Trial Official title: Effectiveness and cost‐effectiveness of conservative and operative treatment of three‐ and four‐part fractures of the proximal humerus. A nested randomised controlled trial and cohort study
Methods	Randomised single‐blind (outcomes assessor)
Participants	90 older participants with comminuted, displaced fractures of the proximal humerus Inclusion criteria: age 65 years or older; acute trauma with randomisation within 7 days of injury; 3‐ or 4‐part fracture with > 5 mm dislocation of the anatomic neck (AO classification C1‐2 for non‐luxation fractures; C3 for luxation fractures)
Interventions	1. [PHILOS]* locking plate: open reduction of the fracture (and glenohumeral joint), internal fixation with the [PHILOS]* locking plate. Tuberculum fragments are sutured to the plate with thick non‐absorbable suture. 2. [Global FX]* hemiarthroplasty: replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick non‐absorbable sutures. 3. Non‐surgical treatment: immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation programme supported by a physiotherapist until 12 weeks after the injury.
Outcomes	Follow‐up: 24 months Primary outcomes: Pain at rest and activity (Numeric Rating Scale), Constant score Secondary outcomes: Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality‐of‐life assessment (15D), subjective patient satisfaction, complications and costs
Starting date	November 2010 End date: December 2021 (December 2019 = final data collection date for primary outcome)
Contact information	Tuomas Lähdeoja, MD: tuomas.lahdeoja@hus.fi Mika Paavola, MD: mika.paavola@hus.fi Helsinki University, Helsinki, Finland
Notes	As of registration update (22 January 2012), the study was recruiting. Start and end dates amended.  Entry for trial (clinicaltrials.gov) on 19 January 2015 indicated that this "study is currently recruiting participants"; "Verified October 2014 by Helsinki University". Study completion date changed from November 2014 to December 2018. The estimated enrolment dropped from 150 to 90. Entry for trial (clinicaltrials.gov) on 3 March 2020 indicated that the study was "recruiting" on 6 June 2018. Study completion date changed from December 2018 to December 2021. The estimated enrolment dropped from 150 to 90. *The names of the locking plate and hemiarthroplasty are no longer present in the 6 June 2018 version of the trial registration.