Study rationale
Cast position trial is a pragmatic NITEP trial; a randomized, multicenter trial that compares the two commonly used cast immobilization positions of distal radius fracture (DRF); volar-flexion ulnar-deviation (“Cotton-Loder”) and functional cast position in primarily successfully reduced, dorsally displaced DRFs in patients aged 65 and over. DRFs are the most common fractures of the upper extremity, often due to low-energy trauma such as falls. Despite their frequency especially in older adults, optimal non-operative treatment remains debated. Over the years, various immobilization methods have been described for the treatment of DRFs. There is, however, a scarcity of studies that compare different cast immobilization methods and there before the trial there was not enough good-quality evidence to enable the selection of one preferable method over the others. The cast position trial was performed to fill this evidence gap of optimal management strategy in most typical, dorsally dislocated (Colles’ fracture) DRFs of patients aged 65 and older.
Study design
The cast position trial was a randomized, controlled, multicenter trial that compared the two commonly used cast immobilization positions, volar-flexion ulnar-deviation (VFUDC) position and functional cast (FC) position in primarily successfully reduced, dorsally displaced DRFs in patients aged 65 or more. It was hypothesized that both positions result in similar functional results. The trial was conducted at 3 large emergency hospitals in Finland; Tampere University Hospital (Tampere), Central Finland Central Hospital (Jyväskylä), and Satakunta Central Hospital (Pori). All consecutive patients aged 65 years and more with a successfully reduced, dorsally displaced DRF were eligible for inclusion. There were no definitive radiographic criteria for the inclusion. After the diagnosis and assessment of informed consent, the patients were randomized to either VFUDC or FC cast position group. Both casts were below elbow, dorsally placed casts.
The follow-up was 12 months. The primary outcome measure was the patient-rated wrist evaluation (PRWE) score 12 months after the fracture. The secondary outcomes were Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale. The number of complications was also recorded.
Status
Recruitment for the trial was finished in May 2018. The results of 12 months and 24 months follow-up have been published in open-access journals, as well as the cost-analysis of the trial.
