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

This study is currently recruiting participants.
Verified April 2012 by Koege Sygehus
Sponsor:
Collaborator:
Region Sealand Healthscince Researchfund
Information provided by (Responsible Party):
Thomas Juul Sørensen, Koege Sygehus
ClinicalTrials.gov Identifier:
NCT01576224
First received: April 9, 2012
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Distal Radius Fracture
 Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Koege Sygehus:

Primary Outcome Measures:
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Disability of arm, shoulder and hand score (DASH) [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of motion [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576224

Contacts
Contact: Thomas J Sørensen, Senior resident +4520959106 tjs@dadlnet.dk
Contact: Susanne K Mallet, Consultant +4526731451 skm@regionsjaelland.dk

Locations
Denmark
Køge Sygehus Recruiting
Køge, Denmark, 4600
Contact: Thomas J Sørensen, Senior resident     +4520959106     tjs@dadlnet.dk    
Principal Investigator: Thomas J Sørensen, Senior resident            
Sponsors and Collaborators
Koege Sygehus
Region Sealand Healthscince Researchfund
  More Information

No publications provided

Responsible Party: Thomas Juul Sørensen, Principal Investigator, Koege Sygehus
ClinicalTrials.gov Identifier: NCT01576224     History of Changes
Other Study ID Numbers: SJ-275
Study First Received: April 9, 2012
Last Updated: April 24, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Koege Sygehus:
Volar locking plate osteosynthesis
Early mobilization
DASH

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on June 17, 2013