Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Colles' Fracture Clinical Trial

— GitRa  

Official title:

A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798614
• Other study ID #: GR-0102
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: June 14, 2016
• Start date: September 2002
• Est. completion date: January 2010

Study information

• Verified date: June 2016
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Description:

Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Distal radius fracture with intact ulna (except for processus styloideus ulnae)

• Dorsal angulation 5-40 degrees

• Axial compression < 4 mm

• Intra articular step-off < 1 mm

• Low energy trauma

• Closed fracture

• Suitable for treatment with closed reduction and plaster cast fixation

Exclusion Criteria:

• Fracture older than 3 Days

• Previously fractured ipsi- or contralateral wrist

• Dementia

• Inflammatory joint disorder

Study Design

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

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• 10-day cast
Removal of plaster cast fixation 10 days after reduction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic displacement	Change in dorsal angulation, radial angulation and axial compression between follow-ups.	At admission, 10 days, 1 month and 12 months	No
Secondary	Grip strength	Grip strength compared to uninjured side at 1, 4 and 12 months	Uninjured side. Injured side at 1, 4 , 12 months	No
Secondary	Range of motion	Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.	Uninjured side. Injured side at 1, 4 and 12 months	No
Secondary	Assessment of pain intensity	Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months	10 days, 1, 4 and 12 months	No
Secondary	Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.	The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),	12 months	No