Dynamic External Fixation in Treatment Distal Radius Fractures

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-05-01

Brief Summary

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A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).

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Detailed Description

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Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.

Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.

Conditions

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Distal Radius Fracture Multiple Trauma Elderly Person Maltreatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients were randomized by drawing lots currency (Face = A - treatment with fixation "non-bridging"; Crown = B - Treatment with the method "bridging"), which were printed and placed in sealed envelopes before the study started.

Study Groups

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Bridging (control group)

External fixation in treatment the distal radius fracture

Group Type PLACEBO_COMPARATOR

External fixation in treatment the distal radius fracture

Intervention Type PROCEDURE

Compare two techniques

Nonbridging (tested group)

External fixation in treatment the distal radius fracture improve grip strength?

Group Type ACTIVE_COMPARATOR

External fixation in treatment the distal radius fracture

Intervention Type PROCEDURE

Compare two techniques

Interventions

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External fixation in treatment the distal radius fracture

Compare two techniques

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* skeletally mature patients, elderly (60 y.o. or more)
* all with a diagnosis of unstable distal radius fractures (AO type A or C)
* associated a multiple injured ( polytrauma ).