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

Not Applicable

Completed

• Conditions: Colles' Fracture
• Interventions: Device: 10-day cast

• Registration Number: NCT02798614
• Lead Sponsor: Uppsala University Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-day cast	10-day cast	Removal of plaster cast 10 Days after reduction

Primary Outcome Measures

Name	Time	Method
Radiographic displacement	At admission, 10 days, 1 month and 12 months	Change in dorsal angulation, radial angulation and axial compression between follow-ups.

Secondary Outcome Measures

Name	Time	Method
Assessment of pain intensity	10 days, 1, 4 and 12 months	Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
Range of motion	Uninjured side. Injured side at 1, 4 and 12 months	Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
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.	12 months	The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
Grip strength	Uninjured side. Injured side at 1, 4 , 12 months	Grip strength compared to uninjured side at 1, 4 and 12 months