Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures (GitRa)

June 14, 2016 updated by: Albert Christersson, Uppsala University Hospital

A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Distal radius fracture with intact ulna (except for processus styloideus ulnae)
  • Dorsal angulation 5-40 degrees
  • Axial compression < 4 mm
  • Intra articular step-off < 1 mm
  • Low energy trauma
  • Closed fracture
  • Suitable for treatment with closed reduction and plaster cast fixation

Exclusion Criteria:

  • Fracture older than 3 Days
  • Previously fractured ipsi- or contralateral wrist
  • Dementia
  • Inflammatory joint disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10-day cast
Removal of plaster cast 10 Days after reduction
Device: 10-day cast
Removal of plaster cast fixation 10 days after reduction
No Intervention: 1-month cast
Removal of plaster cast 1 month after reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic displacement
Time Frame: At admission, 10 days, 1 month and 12 months
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
At admission, 10 days, 1 month and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Uninjured side. Injured side at 1, 4 , 12 months
Grip strength compared to uninjured side at 1, 4 and 12 months
Uninjured side. Injured side at 1, 4 , 12 months
Range of motion
Time Frame: Uninjured side. Injured side at 1, 4 and 12 months
Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
Uninjured side. Injured side at 1, 4 and 12 months
Assessment of pain intensity
Time Frame: 10 days, 1, 4 and 12 months
Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
10 days, 1, 4 and 12 months
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
Time Frame: 12 months
The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Investigators

  • Principal Investigator: Albert Christersson, MD, Department of Orthopaedics, University Hospital of Uppsala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colles' Fracture

Clinical Trials on 10-day cast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe