Optimal Duration of Longitudinal Mechanical Traction in Displaced Radius Fractures: a Prospective Non-inferiority Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuzerner Kantonsspital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Longitudinal mechanical traction

    Procedure/Surgery

    Continuous 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

36 Participants
are divided into 1 treatment group
Group A: Sequential traction (1, 5 and 10 minutes)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of tracti
2

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
3

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
4

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction

Secondary outcomes

1

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 frame
After 1, 5 and 10 minutes of traction
2

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
3

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction
4

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.

Time frame
Before traction (0 minutes) and after 1, 5 and 10 minutes of traction

Other outcomes

Sponsors and contacts

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