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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27696

Enrollment

108

Registered

2010-09-06

Start date

2010-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric distal radius torus fracture

Interventions

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

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).

Eligibility

Inclusion criteria

Inclusion criteria: 1. A torus fracture of the distal radius; 2. Age 5-15.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Painscore (VAS 1-100): Mean score day 1-4.	—

Secondary

Measure	Time frame
1. 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).	—

Measure

Time frame

1. 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).

—

Contacts

Public ContactCindy Brusse

Lijnbaan 32

cindyzpd@hotmail.com+31 (0)70 3302000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)