NCT01576224

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

April 9, 2012

Last Update Submit

January 23, 2017

Conditions

Distal Radius Fracture

Keywords

Volar locking plate osteosynthesisEarly mobilizationDASH

Outcome Measures

Primary Outcomes (4)

  • Disability of arm, shoulder and hand score (DASH)

    After 4 weeks

  • Disability of arm, shoulder and hand score (DASH)

    After 3 months

  • Disability of arm, shoulder and hand score (DASH)

    After 6 months

  • Disability of arm, shoulder and hand score (DASH)

    After 12 months

Secondary Outcomes (8)

  • Range of motion

    After 4 weeks

  • Range of motion

    After 3 months

  • Range of motion

    After 6 months

  • Range of motion

    After 12 months

  • Grip strength

    After 4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Immediate mobilization

EXPERIMENTAL

Patients start exercises immediately after osteosynthesis.

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

Later mobilization

ACTIVE COMPARATOR

Patients are allowed exercises after 14 days.

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

Interventions

Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, DenmarkDEVICE

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

Immediate mobilizationLater mobilization

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Sygehus

Køge, Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Thomas J Sørensen, Consultant

    Køge Sygehus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 12, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)