Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)—a study protocol for a pragmatic randomized controlled trial
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Background: The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures. Methods: A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality. Discussion: The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery. Trial registration: Clinicaltrials.govNCT04574336. Registered on 5 October 2020.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 453 |
| Tidsskrift | Trials |
| Vol/bind | 23 |
| ISSN | 1745-6215 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The trial is part of a PhD study and tuitions to the University of Southern Denmark are funded by the department of Orthopedic Surgery of Kolding Hospital and the PhD-fund of the Region of Southern Denmark. Furthermore, the principal investigator (DK) is guaranteed a salary from the department during the study period. Surgical and non-surgical devices are available at all trial sites as part of usual care and will be covered by the sites, if funding is not fully or partly obtained. External funding has been received by The free and Strategic Research Foundation of Southern Denmark (ref no.: 20/43018), The Cross-regional Research Foundation of The Southern and The Zealand Regions (ref no.: A789) and The Research Council of Lillebaelt Hospital (ref no.: 2020-16) for operational costs for a central and local coordinating project employee and for partly funding the costs connected to recruiting. The current and future funders had no role in the design, execution, analysis, data interpretation, or decision to submit results. No industrial funding is involved.
Funding Information:
The authors would like to acknowledge and give special thanks to Dr. Peter Tengberg and Dr. Cecilia Rogmark for their valuable contributions related to the networking of researchers across Denmark, Norway, and Sweden. Further thanks to Mr. Michael Rosenfeldt for the illustration. SHAFT collaborators Katharina Stohlmann, Patient representative Bamo Jalal, Zealand University Hospital Christian Cavallius, Kolding Hospital Esben S. Pedersen, Aalborg University Hospital Frede Frihagen, Østfold Hospital Trust Frederik Stensbirk, Holbæk Hospital Henrik Illerström, Stockholm South General Hospital Jens Knak, Aarhus University Hospital Anne Marie Nyholm, Herlev-Gentofte University Hospital of Copenhagen Jesper Schønnemann, Hospital of Southern Denmark Joakim Jensen, Odense University Hospital Jonas Sundkvist, Umeå University Hospital Mads Vinding, Slagelse Hospital Peter M. Siesing, New North Zealand University Hospital of Copenhagen Srdjan Zivanovic, Viborg Regional Hospital Søren Kring, Hvidovre University Hospital of Copenhagen Steering committee (SC) (see title page for members) All lead investigators will be SC members including the patient representative Miss Katharina Stohlmann. The SC is organized to administrate the trial by reviewing the progress of the study and if necessary, discuss changes to the protocol and/or investigators brochure to facilitate the smooth running of the study. SHAFT authorship agreement The first authorship will be granted after the first patient has completed the trial endpoint at 52 weeks. A recruiting site will then be granted an additional authorship for every 5 patients that complete the trial endpoint at 52 weeks. All authors are expected to provide substantially to the data collection. The authorships are granted the departments and not individuals.
Publisher Copyright:
© 2022, The Author(s).
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