About this trial
The goal of this clinical trial is to learn if 1 minute of mechanical traction lines up a broken wrist bone as well as 5 or 10 minutes of traction in adults (18 years and older) who come to the emergency department with a displaced distal radius fracture (a broken wrist with the bone pieces out of place) that needs to be set and put in a cast. The main questions it aims to answer are:
Is the bone position on X-ray after 1 minute of traction no worse than after 5 or 10 minutes? Bone position is measured as wrist tilt, radial inclination, radial height and ulnar variance.
At what point during traction does the bone reach its best position?
There is no separate comparison group. Each participant serves as their own comparison. Researchers will compare X-rays taken before traction and after 1, 5 and 10 minutes of traction in the same participant to see if longer traction improves bone alignment.
Participants will:
Receive standard pain relief and have their arm placed in traction with finger loops and a 5 kg weight, as in usual care Have two extra wrist X-rays (front and side view) after 1 minute and again after 5 minutes of traction, in addition to the standard X-rays before traction and after 10 minutes Have their fracture set and a cast applied as usual. Participation ends when they leave the emergency department, and there are no extra follow-up visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Longitudinal mechanical traction
Procedure/SurgeryContinuous longitudinal traction with standardized finger traps and a 5 kg weight over a pulley on the emergency department reduction frame, lasting 10 minutes. Wrist radiographs are taken at 1, 5 and 10 minutes of traction.
Treatment groups
Trial outcomes
Primary outcomes
Change in volar/dorsal tilt
Volar or dorsal tilt of the distal radius (degrees), measured on the lateral wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees.
Change in radial inclination
Radial inclination (degrees), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 5 degrees.
Change in radial height
Radial height (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm.
Change in ulnar variance
Ulnar variance (mm), measured on the posteroanterior wrist radiograph. The difference between time points is compared against a non-inferiority margin of 2 mm.
Secondary outcomes
Proportion of fractures with acceptable radiological alignment
Percentage of participants whose fracture meets acceptable alignment criteria for volar/dorsal tilt, radial inclination, radial height and ulnar variance at each traction time point.
Time point of maximal radiological realignment
The traction time point (1, 5 or 10 minutes) at which each of the four radiological parameters (volar/dorsal tilt, radial inclination, radial height, ulnar variance) reaches its maximal correction relative to baseline.
Effect of fracture morphology on change in radiological alignment
Association between fracture type (AO/OTA 23-A, 23-B, 23-C) and baseline displacement, and the change in the four radiological parameters over time. This is analysed with linear mixed-effects models.
Effect of age and sex on change in radiological alignment
Association between patient age and sex and the change in the four radiological parameters over time. This includes a sex × time interaction, analysed with linear mixed-effects models.
Sponsors and contacts
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