Paediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: Mitella versus plaster cast.

Torus fractures of the wrist are a common injury amongst children. It is a very simple fracture, that can easily be missed during clinical examination. An X-ray will show a buckle on te cortex of the bone. Traditionally, these simple and stable fractures are treated with a below the elbow short arm cast. Recent studies have considered looking at treatment alternatives. These studies showed that this stable fracture does not need long term immobilsation in a cast, and that treatment with soft bandages and removable splints is a safe alternative with many benefits. S. Gryllis Allison mentioned that treatment with only a mitella and no furthur immobilsation will be enough, because the fracture is stable and studies have shown that the use of support bandages is of little of no use in promoting stability and encouraging recovery. Watts and Armstrong found that the use of support bandages does not reduce recovery time and may increase the need for analgesia in EDs. Studies have shown that treatment with soft bandages or removable splints is more comfortable and that a quicker return to normal function is achieved in comparison with cast therapy.



We will compare a group treated with a sling versus a grroup treated with a plastercast. If the study shows that the treatment with a sling gives an earlier return to normal function en does not give a clinically significant difference in pain experience compared to cast therapy than the traditional treatment can be adjusted. We aim at contributing to a national or international guideline in the future. It is a non-inferiority study. This means that the children from the slinggroup are allowed te have a little bit more pain than the castgroup if their return to normal function is faster. They are not allowed to have clinically significant more pain than the cast group. This means a difference of 10-15 point on a 100-pointscale. If there is a clinically significant difference in pain, than the standard casttreatment will not be changed. The study will be a randomized controlled trial (RCT), single blinded ( The doctors who examine the patients weekly in the outpatient clinic are blinded for therapy. Slings and casts are removed by the researchers before patients enter the room of the examiner. Patiënts are instructed not to tell the type of their therapy).



Randomisation will lead to two groups: A. Sling B. Cast. The children will be treated fot two weeks with the sling or the cast. The study will last 6 weeks.

If the study shows that the treatment with a sling gives an earlier return to normal function en does not give a clinically significant difference in pain experience compared to cast therapy than the traditional treatment can be adjusted. We aim at contributing to a national or international guideline in the future. It is a non-inferiority study. This means that the children from the slinggroup are allowed te have a little bit more pain than the castgroup if their return to normal function is faster. They are not allowed to have clinically significant more pain than the cast group. This means a difference of 10-15 point on a 100-pointscale. If there is a clinically significant difference in pain, than the standard casttreatment will not be changed.

Day 0, day 4, 1-2-6 weeks.

We will compare a group treated with a sling versus a grroup treated with a plastercast. If the study shows that the treatment with a sling gives an earlier return to normal function en does not give a clinically significant difference in pain experience compared to cast therapy than the traditional treatment can be adjusted. We aim at contributing to a national or international guideline in the future. It is a non-inferiority study. This means that the children from the slinggroup are allowed te have a little bit more pain than the castgroup if their return to normal function is faster. They are not allowed to have clinically significant more pain than the cast group. This means a difference of 10-15 point on a 100-pointscale. If there is a clinically significant difference in pain, than the standard casttreatment will not be changed. The study will be a randomized controlled trial (RCT), single blinded (the doctors who examine the patients weekly in the outpatient clinic are blinded for therapy). Slings and casts are removed by the researchers before patients enter the room of the examiner. Patiënts are instructed not to tell the type of their therapy. Randomisation will lead to two groups:

A. Sling;

B. Cast.

The children will be treated fot two weeks with the sling or the cast. The study will last 6 weeks. The primary outcome score is the mean painscore of day 1-4 (VAS 1-100).