Dorsal Splint or Circular Cast for Colles' Fracture?

Colles' Fracture Clinical Trial

Official title:

Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470691
• Other study ID #: StOlavsH-ort-radius
• Status: Completed
• Phase: N/A
• First received: May 7, 2007
• Last updated: April 7, 2015
• Start date: June 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery.

The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• women 50 years and older

• Colles' fracture due to low energy trauma

Exclusion Criteria:

• high energy trauma

• age under 50 years

• dementia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

Procedure:
• plaster cast
complete circular plaster cast
• dorsal splint
dorsal plaster splint

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Wik TS, Aurstad AT, Finsen V. Colles' fracture: dorsal splint or complete cast during the first 10 days? Injury. 2009 Apr;40(4):400-4. doi: 10.1016/j.injury.2008.08.044. Epub 2009 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	redisplacement	dorsal angulation, radial tilt and radial shortening - radiographs	10 days	No
Secondary	pain	pain during past 24h on a VAS	10 days	No
Secondary	number of analgesic tablets	number of analgesic tablets taken during the 10 days after reduction.	10 days	No