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CompletedNCT01576224E-MOBUpdated Jan 25, 2017

Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures

An interventional study of Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark in Distal Radius Fracture, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Distal Radius Fracture

Keywords

  • Volar locking plate osteosynthesis
  • Early mobilization
  • DASH
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 100 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Over 50 years of age
  • Distal radius fracture suitable for volar locking plate osteosynthesis
  • Inhabitants in Region Sjaelland

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Immediate mobilization

    Patients start exercises immediately after osteosynthesis.

    Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark

  • Active comparator
    Later mobilization

    Patients are allowed exercises after 14 days.

    Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark

Interventions

  • DeviceRemovable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark

    To be removed during training exercises three to five times a day

06

What researchers measure

Primary outcomes

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

    Time frame: After 4 weeks

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

    Time frame: After 3 months

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

    Time frame: After 6 months

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

    Time frame: After 12 months

Secondary outcomes

  1. Range of motion

    Time frame: After 4 weeks

  2. Range of motion

    Time frame: After 3 months

  3. Range of motion

    Time frame: After 6 months

  4. Range of motion

    Time frame: After 12 months

  5. Grip strength

    Time frame: After 4 weeks

  6. Grip strength

    Time frame: After 3 months

  7. Grip strength

    Time frame: After 6 months

  8. Grip strength

    Time frame: After 12 months

07

Study locations

1 site
  • Køge Sygehus
    Køge, 4600, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01576224
Lead sponsor
Zealand University Hospital
Collaborators
Region Sjællands sundhedsvidenskabelige Forskningsfond
Responsible party
Thomas Juul Sørensen (Principal Investigator, Zealand University Hospital) — Principal investigator
First posted
Apr 12, 2012
Start date
Jan 2012
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Jan 25, 2017

Study contacts

Thomas J Sørensen, Consultant
principal investigator · Køge Sygehus, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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