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

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Volar locking plate osteosynthesis, Early mobilization, DASH

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Køge Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate mobilization

Later mobilization

Arm Description

Patients start exercises immediately after osteosynthesis.

Patients are allowed exercises after 14 days.

Outcomes

Primary Outcome Measures

Disability of arm, shoulder and hand score (DASH)
Disability of arm, shoulder and hand score (DASH)
Disability of arm, shoulder and hand score (DASH)
Disability of arm, shoulder and hand score (DASH)

Secondary Outcome Measures

Range of motion
Range of motion
Range of motion
Range of motion
Grip strength
Grip strength
Grip strength
Grip strength

Full Information

First Posted
April 9, 2012
Last Updated
January 23, 2017
Sponsor
Zealand University Hospital
Collaborators
Region Sjællands sundhedsvidenskabelige Forskningsfond
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1. Study Identification

Unique Protocol Identification Number
NCT01576224
Brief Title
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures
Acronym
E-MOB
Official Title
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
Collaborators
Region Sjællands sundhedsvidenskabelige Forskningsfond

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Volar locking plate osteosynthesis, Early mobilization, DASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate mobilization
Arm Type
Experimental
Arm Description
Patients start exercises immediately after osteosynthesis.
Arm Title
Later mobilization
Arm Type
Active Comparator
Arm Description
Patients are allowed exercises after 14 days.
Intervention Type
Device
Intervention Name(s)
Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
Intervention Description
To be removed during training exercises three to five times a day
Primary Outcome Measure Information:
Title
Disability of arm, shoulder and hand score (DASH)
Time Frame
After 4 weeks
Title
Disability of arm, shoulder and hand score (DASH)
Time Frame
After 3 months
Title
Disability of arm, shoulder and hand score (DASH)
Time Frame
After 6 months
Title
Disability of arm, shoulder and hand score (DASH)
Time Frame
After 12 months
Secondary Outcome Measure Information:
Title
Range of motion
Time Frame
After 4 weeks
Title
Range of motion
Time Frame
After 3 months
Title
Range of motion
Time Frame
After 6 months
Title
Range of motion
Time Frame
After 12 months
Title
Grip strength
Time Frame
After 4 weeks
Title
Grip strength
Time Frame
After 3 months
Title
Grip strength
Time Frame
After 6 months
Title
Grip strength
Time Frame
After 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Sørensen, Consultant
Organizational Affiliation
Køge Sygehus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Køge Sygehus
City
Køge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures

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