Dorsal Splint or Circular Cast for Colles' Fracture? - Full Text View

Sponsor:	St. Olavs Hospital
Information provided by (Responsible Party):	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00470691

Purpose

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.

Condition	Intervention
Colles' Fracture	Procedure: plaster cast Procedure: dorsal splint

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:

redisplacement [ Time Frame: 10 days ] [ Designated as safety issue: No ]
dorsal angulation, radial tilt and radial shortening - radiographs

Secondary Outcome Measures:

pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]
pain during past 24h on a VAS
number of analgesic tablets [ Time Frame: 10 days ] [ Designated as safety issue: No ]
number of analgesic tablets taken during the 10 days after reduction.

Enrollment:	72
Study Start Date:	June 2004
Study Completion Date:	June 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: complete plaster cast reduction and a complete plaster cast,	Procedure: plaster cast complete circular plaster cast
Active Comparator: dorsal plaster splint reduction and a dorsal plaster splint.	Procedure: dorsal splint dorsal plaster splint

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

high energy trauma
age under 50 years
dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470691

Locations

Norway
St. Olavs Hospital
Trondheim, Norway

Sponsors and Collaborators

St. Olavs Hospital

Investigators

Study Chair:

Vilh Finsen, MD, PhD

Dept of orthopaedic Surgery, St Olavs Hospital

More Information

Publications:

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. Epub 2009 Feb 4.

Responsible Party:	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00470691 History of Changes
Other Study ID Numbers:	StOlavsH-ort-radius
Study First Received:	May 7, 2007
Last Updated:	October 20, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012