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Dorsal Splint or Circular Cast for Colles' Fracture?

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ClinicalTrials.gov Identifier: NCT00470691
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease Intervention/treatment Phase
Colles' Fracture Procedure: plaster cast Procedure: dorsal splint Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
Study Start Date : June 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. redisplacement [ Time Frame: 10 days ]
    dorsal angulation, radial tilt and radial shortening - radiographs


Secondary Outcome Measures :
  1. pain [ Time Frame: 10 days ]
    pain during past 24h on a VAS

  2. number of analgesic tablets [ Time Frame: 10 days ]
    number of analgesic tablets taken during the 10 days after reduction.



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00470691     History of Changes
Other Study ID Numbers: StOlavsH-ort-radius
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Fractures, Bone
Colles' Fracture
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Radius Fractures