NCT00470691

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

May 7, 2007

Last Update Submit

April 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • redisplacement

    dorsal angulation, radial tilt and radial shortening - radiographs

    10 days

Secondary Outcomes (2)

  • pain

    10 days

  • number of analgesic tablets

    10 days

Study Arms (2)

complete plaster cast

EXPERIMENTAL

reduction and a complete plaster cast,

Procedure: plaster cast

dorsal plaster splint

ACTIVE COMPARATOR

reduction and a dorsal plaster splint.

Procedure: dorsal splint

Interventions

plaster castPROCEDURE

complete circular plaster cast

complete plaster cast
dorsal splintPROCEDURE

dorsal plaster splint

dorsal plaster splint

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • high energy trauma
  • age under 50 years
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, Norway

Location

Related 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.

MeSH Terms

Conditions

Colles' Fracture

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesRadius FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Vilh Finsen, MD, PhD

    Dept of orthopaedic Surgery, St Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

June 1, 2004

Primary Completion

January 1, 2008

Study Completion

June 1, 2008

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations