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Dorsal Splint or Circular Cast for Colles' Fracture?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00470691
First received: May 7, 2007
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  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:

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 May 21, 2013