Treatment of Distal Radius Fractures in Elderly Patients

NCT ID: NCT00788190

Last Updated: 2011-04-11

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

WITHDRAWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

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The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

Detailed Description

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* Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
* Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
* Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Conditions

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Distal Radius Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Surgery

Surgical intervention to reduce Distal Radius Fracture

Group Type OTHER

Distal Radius Fracture Reduction

Intervention Type PROCEDURE

Surgical Intervention to Reduce Distal Radius Fracture

Conservative Treatment

Conservative treatment of Distal Radius Fractures

Group Type OTHER

Conservative Management

Intervention Type OTHER

Conservative management of Distal Radius Fractures

Interventions

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Distal Radius Fracture Reduction

Surgical Intervention to Reduce Distal Radius Fracture

Intervention Type PROCEDURE

Conservative Management

Conservative management of Distal Radius Fractures

Intervention Type OTHER

Other Intervention Names

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Distal Radius Reduction

Eligibility Criteria

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Inclusion Criteria

* Distal Radius Fracture
* Between 10 and 20 degrees of dorsal angulation
* Between 3 and 5mm of Ulnar positive variance
* Between 1 and 2mm intra Articular Step deformity
* Age 65 and older

Exclusion Criteria

* Pre-Morbid medical conditions which preclude surgical intervention
* Patients who do not live independently.
* Patients with an open fracture
* Associated soft tissue or skeletal injury to the same limb.
* Pre-existing wrist arthrosis or disability
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LHRI- Lawson Health Research Institute

UNKNOWN

Sponsor Role collaborator

Hand and Upper Limb Clinic, Canada

NETWORK

Sponsor Role lead

Responsible Party

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St. Joseph's hospital

Principal Investigators

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Joy C MacDermid, PhD

Role: PRINCIPAL_INVESTIGATOR

Hand and Upper Limb Centre, St. Joseph's Health Care

Ruby Grewal, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hand and Upper Limb Centre, St Joseph's Health Care

Locations

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Hand and Upper Limb Centre

London, Ontario, Canada

Site Status

Hand and upper Limb Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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LHRI 001

Identifier Type: -

Identifier Source: org_study_id

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