Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures (E-MOB)

January 23, 2017 updated by: Thomas Juul Sørensen, Zealand University Hospital

Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.

The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.

The primary hypothesis is, that immediate training leads to earlier and faster recovery.

Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Køge Sygehus

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:

  • Over 50 years of age
  • Distal radius fracture suitable for volar locking plate osteosynthesis
  • Inhabitants in Region Sjaelland

Exclusion Criteria:

  • Dementia
  • Abuse of drugs, medication or alcohol
  • Open fractures
  • Multitrauma or other injures on same extremity
  • Earlier wrist fracture
  • Delay of osteosynthesis of more than 14 days

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate mobilization
Patients start exercises immediately after osteosynthesis.
Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
To be removed during training exercises three to five times a day
Active Comparator: Later mobilization
Patients are allowed exercises after 14 days.
Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
To be removed during training exercises three to five times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disability of arm, shoulder and hand score (DASH)
Time Frame: After 4 weeks
After 4 weeks
Disability of arm, shoulder and hand score (DASH)
Time Frame: After 3 months
After 3 months
Disability of arm, shoulder and hand score (DASH)
Time Frame: After 6 months
After 6 months
Disability of arm, shoulder and hand score (DASH)
Time Frame: After 12 months
After 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of motion
Time Frame: After 4 weeks
After 4 weeks
Range of motion
Time Frame: After 3 months
After 3 months
Range of motion
Time Frame: After 6 months
After 6 months
Range of motion
Time Frame: After 12 months
After 12 months
Grip strength
Time Frame: After 4 weeks
After 4 weeks
Grip strength
Time Frame: After 3 months
After 3 months
Grip strength
Time Frame: After 6 months
After 6 months
Grip strength
Time Frame: After 12 months
After 12 months

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Collaborators

Region Sjællands sundhedsvidenskabelige Forskningsfond

Investigators

  • Principal Investigator: Thomas J Sørensen, Consultant, Køge Sygehus, Denmark

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

January 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 9, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-275

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.

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