Dorsal Splint or Circular Cast for Colles' Fracture?

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00470691
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2004
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. redisplacement [10 days]

   dorsal angulation, radial tilt and radial shortening - radiographs

Secondary Outcome Measures

1. pain [10 days]

   pain during past 24h on a VAS

2. number of analgesic tablets [10 days]

   number of analgesic tablets taken during the 10 days after reduction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT00470691
• Other Study ID Numbers: StOlavsH-ort-radius
• First Posted: May 8, 2007
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Colles' Fracture; Fractures, Bone

Study Results

No Results Posted as of Apr 8, 2015