NCT00989222

Brief Summary

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 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, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
Last Updated

October 5, 2009

Status Verified

October 1, 2009

Enrollment Period

3.4 years

First QC Date

October 2, 2009

Last Update Submit

October 2, 2009

Conditions

Radius Fractures

Keywords

Distal radius fracturesFractures of the distal radiusVolar plateExternal fixation

Outcome Measures

Primary Outcomes (1)

  • PRWE (patient rated wrist evaluation) score

    3,6 and 12 months

Secondary Outcomes (1)

  • Objective function (range of movement and grip strength)

    3,6 and 12 months

Study Arms (2)

Volar locked plate

OTHER

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Procedure: Internal fixation with a volar locked plate

External fixation

OTHER

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Procedure: closed reduction and external fixation

Interventions

closed reduction and external fixationPROCEDURE

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Also known as: External fixation: Hoffman compact
External fixation
Internal fixation with a volar locked platePROCEDURE

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Also known as: Volar locked plate brand: Königsee by Swemac
Volar locked plate

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
  • Patient aged 20-70 years with no previous fracture of either wrist.

You may not qualify if:

  • Bilateral fractures,
  • Other current injury to the upper extremities,
  • Dementia, OR
  • Severe comminution or too small distal fragment to allow plating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, S-18288, Sweden

Location

MeSH Terms

Conditions

Radius FracturesWrist Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, BoneWrist Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Gustaf Neander, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 5, 2009

Record last verified: 2009-10

Locations

SE(1)