We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dorsal Splint or Circular Cast for Colles' Fracture?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470691
First Posted: May 8, 2007
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Olavs Hospital
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

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


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

  • number of analgesic tablets [ Time Frame: 10 days ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00470691     History of Changes
Other Study ID Numbers: StOlavsH-ort-radius
First Submitted: May 7, 2007
First Posted: May 8, 2007
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