Pedersen, Jonas
Mortensen, Simon Oksbjerre
Rölfing, Jan Duedal
Thorninger, Rikke
Funding for this research was provided by:
Forskningsenheden Regionshospital Randers
Article History
Received: 8 April 2019
Accepted: 11 June 2019
First Online: 29 June 2019
Ethics approval and consent to participate
: This study has been approved by the Danish Scientific Ethical Committee (ID: 1–10–72-420-17) and has been registered at the Danish Data Protection Agency. Protocol modifications are prohibited. Furthermore, this study is registered at Clinicaltrials.gov (ID: NCT03716661). Participation is based on written consent after the possible participant is carefully informed about participation by the including physician or research year student. Only information regarding the therapeutic process of the wrist and associated hospitalizations within the 1 year of follow-up will be extracted from the participants electronic medical journals. The surgical treatment is covered by The Danish Patient Compensation Association.We do not expect that participants experience more and severe complications than those associated to the standard operative treatment. Plaster immobilization may lead to complications e.g. skin irritation, pain, and at rare occasions ulcer due to poorly applied plaster. All patients are given instructions for cast complications. Normally, this can be fixed by replacing the plaster cast. As previously stated, the investigators reserve the right to exclude participants at any time if it is considered clinically irresponsible to let them continue in the study. An interim analysis of the 6 months follow-up data will be performed when half of the patients has reached that milestone. The study will be terminated if treatment arm 2 should be inferior to treatment arm 1 in terms of complication rate. The patient can anytime withdraw their written consent.
: Written consent for publishing has been obtained by the individual in the images for Fig. InternalRef removed.
: RT is consultant for Acumed. The other authors have no conflict of interest.