NCT02670629.
Methods | Randomised, double‐blind controlled trial Study period January 2013 to December 2015 |
Participants | 60 participants, aged 2 to 11 years (eligible) with completely displaced distal radius fractures with or without distal ulna fractures |
Interventions | 1. Closed anatomic reduction under anaesthesia and short cast 2. Closed overriding alignment and short cast. Oral medications only The cast was removed after 6 weeks and rehabilitation in‐house was started as soon as the pain was over |
Outcomes | Follow‐up: Weeks 1, 3, 6 and 10 Primary outcomes: Residual radiographic deformities, radial tilt, radial shortening and radial variation Secondary outcomes: Pain (VAS), residual functional deficits assessed by the Upper Extremity Functional Index, aesthetic results measured by clinical radial alignment |
Notes | JE sent email to Dr Acosta‐Olivo (acostaolivocarlos@gmail.com) 8 March 2017 asking for current plans for publishing the trial results and permission to access individual patient data file on the trial registration website. Reply received from Dr Adriana Hernandez 8 March 2017 confirming that they are planning to publish the results and that permission would need to be granted from the University in Mexico to share the data. Data from the University in Mexico not provided. Awaiting publication of trial report. A conference abstract was identified by JH subsequent to the search and so has not been included in the results of the search (Hernandez 2018) |