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

This study has been completed.
Sponsor:
Collaborator:
Region Sjællands sundhedsvidenskabelige Forskningsfond
Information provided by (Responsible Party):
Thomas Juul Sørensen, Zealand University Hospital
ClinicalTrials.gov Identifier:
NCT01576224
First received: April 9, 2012
Last updated: January 23, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Care Provider, 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:


Further study details as provided by Zealand University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576224

Locations
Denmark
Køge Sygehus
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Region Sjællands sundhedsvidenskabelige Forskningsfond
Investigators
Principal Investigator: Thomas J Sørensen, Consultant Køge Sygehus, Denmark
  More Information

Responsible Party: Thomas Juul Sørensen, Principal Investigator, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01576224     History of Changes
Other Study ID Numbers: SJ-275
Study First Received: April 9, 2012
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Zealand University Hospital:
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 March 29, 2017