Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

NCT ID: NCT01034943

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-02-28

Brief Summary

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Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

Detailed Description

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This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board

Conditions

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Dorsally Displaced Intraarticular Distal Radius Fractures Age 50 - 74 for Females or 60-74 for Males Low Energy Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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External fixation

Operation with external fixation and optional addition of k-wire

Group Type ACTIVE_COMPARATOR

External fixation

Intervention Type PROCEDURE

Operation with external fixation and optional addition of k-wire

Volar plate

Operation with Synthes volar two column plate (TCP)

Group Type ACTIVE_COMPARATOR

Volar plate

Intervention Type PROCEDURE

Operation with a Synthes volar two column plate (TCP)

Interventions

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External fixation

Operation with external fixation and optional addition of k-wire

Intervention Type PROCEDURE

Volar plate

Operation with a Synthes volar two column plate (TCP)

Intervention Type PROCEDURE

Other Intervention Names

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External Fixation with Hoffman external fixator (Stryker) Synthes volar two column plate (TCP)

Eligibility Criteria

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Inclusion Criteria

* Female 50-74 years or male 60-74 years
* Dorsally displaced extraarticular distal radius fracture
* Dorsal angulation \>20 degrees measured from the plane perpendicular to the radius axis
* Low energy trauma
* Injury \<72 hours when diagnosed
* Patient independent of help for ADL

Exclusion Criteria

* Earlier dysfunction in any wrist
* Other major injuries
* Rheumatoid arthritis or other systemic joint disease
* Dementia or severe psychiatric disease
* Severe medical condition making general anesthesia a considerable risk
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Sari Ponzer

Professor, MD, Consultant orthopeadic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sari Ponzer, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Stockholm South Hospital Department of Orthopeadic Surgery

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DRF Extra

Identifier Type: -

Identifier Source: org_study_id

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