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

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.
ClinicalTrials.gov Identifier: NCT01576224
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
Region Sjællands sundhedsvidenskabelige Forskningsfond
Information provided by (Responsible Party):
Thomas Juul Sørensen, Zealand University Hospital

April 9, 2012
April 12, 2012
January 25, 2017
January 2012
February 2014   (Final data collection date for primary outcome measure)
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 4 weeks ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 3 months ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 6 months ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 12 months ]
Same as current
Complete list of historical versions of study NCT01576224 on ClinicalTrials.gov Archive Site
  • Range of motion [ Time Frame: After 4 weeks ]
  • Range of motion [ Time Frame: After 3 months ]
  • Range of motion [ Time Frame: After 6 months ]
  • Range of motion [ Time Frame: After 12 months ]
  • Grip strength [ Time Frame: After 4 weeks ]
  • Grip strength [ Time Frame: After 3 months ]
  • Grip strength [ Time Frame: After 6 months ]
  • Grip strength [ Time Frame: After 12 months ]
  • Range of motion [ Time Frame: After 4 weeks ]
  • Range of motion [ Time Frame: After 3 months ]
  • Range of motion [ Time Frame: After 6 months ]
  • Range of motion [ Time Frame: After 12 months ]
  • Grip strenght [ Time Frame: After 4 weeks ]
  • Grip strenght [ Time Frame: After 3 months ]
  • Grip strenght [ Time Frame: After 6 months ]
  • Grip strenght [ Time Frame: After 12 months ]
Not Provided
Not Provided
 
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures
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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Distal Radius Fracture
Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
To be removed during training exercises three to five times a day
  • Experimental: Immediate mobilization
    Patients start exercises immediately after osteosynthesis.
    Intervention: Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
  • Active Comparator: Later mobilization
    Patients are allowed exercises after 14 days.
    Intervention: Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01576224
SJ-275
Yes
Not Provided
Plan to Share IPD: No
Thomas Juul Sørensen, Zealand University Hospital
Zealand University Hospital
Region Sjællands sundhedsvidenskabelige Forskningsfond
Principal Investigator: Thomas J Sørensen, Consultant Køge Sygehus, Denmark
Zealand University Hospital
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP