NCT00848263

Brief Summary

Fractures of the distal radius are one of the most common orthopaedic injuries and are associated with a high complication rate. There is a lack of clinical trials comparing the different treatment modalities of fractures of the distal radius. The purpose of this randomized trial is to assess differences in functional outcome, radiological results, and complication rate in patients 55 years and older with an unstable displaced fracture of the distal radius without articular involvement treated with a dorsal nail plate or a volar plate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

4.8 years

First QC Date

February 19, 2009

Last Update Submit

November 17, 2014

Conditions

Distal Radius Fractures

Keywords

FractureRadiusSurgeryOsteosynthesis

Outcome Measures

Primary Outcomes (1)

  • DASH score

    52 weeks

Secondary Outcomes (5)

  • PRWE score

    52 weeks

  • EQ-5D score

    52 weeks

  • Grip strength

    52 weeks

  • Radiological result

    52 weeks

  • Pain VAS score (1-10)

    52 weeks

Study Arms (2)

DVR

ACTIVE COMPARATOR

Volar plate

Procedure: Volar plate

DNP

ACTIVE COMPARATOR

Dorsal nail plate

Procedure: Dorsal nail plate

Interventions

Volar platePROCEDURE

Treatment with a volar plate (DVR) inserted through a volar incision of 8-10 cm over the distal radius (Henry's approach).

Also known as: Hand Innovation, DePuy
DVR
Dorsal nail platePROCEDURE

Treatment with a dorsal nail plate (DNP) inserted through a 3-4 cm dorsal incision.

Also known as: Hand Innovation, DePuy
DNP

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unstable dorsally displaced fracture of the distal radius without articular involvement
  • Age 55 years or older

You may not qualify if:

  • Previous fracture of the same wrist
  • More than one acute fracture (except the ulnar styloid process)
  • Open fracture
  • Mental impairment or unable to understand and sign an informed consent
  • Fracture older than 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker and Baerum Hospital

Baerum, Rud, 1309, Norway

Location

MeSH Terms

Conditions

Wrist FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Asbjørn Hjall, M.D.

    Asker and Baerum hospital, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md PhD

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

NO(1)