search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number8412
- NTR NumberNTR2508
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2010
- Secondary IDs30801 CCMO
- Public TitlePaediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: Mitella versus plaster cast.
- Scientific TitlePaediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: mitella versus plaster cast.
- ACRONYMTorus fracture therapy comparison
- hypothesisIf 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.
- Healt Condition(s) or Problem(s) studiedChildren, Distal radius torus fracture
- Inclusion criteria1. A torus fracture of the distal radius;
2. Age 5-15.
- Exclusion criteria1. Greenstick fractures;
2. Torus antebrachii fractures;
3. Children with additional fractures;
4. Children with a metabolic bone disease;
5. Children with special needs;
6. Language barrier;
7. Children living in another region and therefore are followed-up in another hospital.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2010
- planned closingdate1-mrt-2012
- Target number of participants108
- InterventionsWe 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. PatiŽnts 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).
- Primary outcomePainscore (VAS 1-100): Mean score day 1-4.
- Secondary outcome1. Painscore (VAS 1-100): Mean score first week (day 1-7), after 2 and 6 weeks;
2. Wrist function with a questionnaire (0-100). The Acitvities Scale for Kids is a validated questionnaire that has been translated. The first questionnaire is collected at the ED and concerns the 3 previous days before the ED visit. Other questionnaires will be collected after 1, 2 and 6 weeks. Every questionnaire concerns the 3 previous days;
3. Range of motion with goniometer (dorso- and volarflexion of the left and right wrist);
4. Gripstrength (Power (kg) of the left and right hand) The range of motion and gripstrength will be performed in the ED and after 1, 2 and 6 weeks in the outpatient clinic. After 1 week the measurements will be done by two indepent observers to evaluate the precision of this non-validated test Additional variables;
5. Use of pain medication (tablets/day);
6. Discomfort (itching, too heavy, too tight, too wide, other complaints);
7. Comfortability of the treatment (5 point scale: very comfortable to very uncomfortable);
8. Satisfaction of the treatment (5 pointscale: very satisfied to very unsatisfied).
- TimepointsDay 0, day 4, 1-2-6 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Cindy Brusse
- CONTACT for SCIENTIFIC QUERIES Cindy Brusse
- Sponsor/Initiator Medisch Centrum Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Haaglanden
- PublicationsN/A
- Brief summaryTorus 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. PatiŽnts 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.
- Main changes (audit trail)
- RECORD6-sep-2010 - 24-okt-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl