Dorsal Splint or Circular Cast for Colles' Fracture?

NCT ID: NCT00470691

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colles' Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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complete plaster cast

reduction and a complete plaster cast,

Group Type EXPERIMENTAL

plaster cast

Intervention Type PROCEDURE

complete circular plaster cast

dorsal plaster splint

reduction and a dorsal plaster splint.

Group Type ACTIVE_COMPARATOR

dorsal splint

Intervention Type PROCEDURE

dorsal plaster splint

Interventions

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plaster cast

complete circular plaster cast

Intervention Type PROCEDURE

dorsal splint

dorsal plaster splint

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women 50 years and older
* Colles' fracture due to low energy trauma

Exclusion Criteria

* high energy trauma
* age under 50 years
* dementia
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vilh Finsen, MD, PhD

Role: STUDY_CHAIR

Dept of orthopaedic Surgery, St Olavs Hospital

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 19195651 (View on PubMed)

Other Identifiers

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StOlavsH-ort-radius

Identifier Type: -

Identifier Source: org_study_id

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