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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Region Sjællands sundhedsvidenskabelige Forskningsfond
Information provided by (Responsible Party):
Thomas Juul Sørensen, Koege Sygehus
ClinicalTrials.gov Identifier:
NCT01576224
First received: April 9, 2012
Last updated: October 27, 2013
Last verified: October 2013
  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:


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: February 2014
Estimated 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

  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
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
Koege Sygehus
Region Sjællands sundhedsvidenskabelige Forskningsfond
Investigators
Principal Investigator: Thomas Juul Sørensen, Consultant Køge Sygehus, Denmark
  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: October 27, 2013
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
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014