Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Study Overview
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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).

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.

Official Title
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Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study

Conditions
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Distal Radius Fracture, Multiple Trauma, Elderly Person Maltreatment

Intervention / Treatment
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* Procedure: External fixation in treatment the distal radius fracture


Participation Criteria
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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 ). Exclusion Criteria: ongoing chemo or radiotherapy, mental illness, alcohol abuse.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Bridging (control group)<br>External fixation in treatment the distal radius fracture | Procedure: External fixation in treatment the distal radius fracture<br>* Compare two techniques<br>|
| Active Comparator: Nonbridging (tested group)<br>External fixation in treatment the distal radius fracture improve grip strength? | Procedure: External fixation in treatment the distal radius fracture<br>* Compare two techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strenght | use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of wrist motion | use the specific goniometer to measure the arc of movement the wrist | 12 months | 
| Radiograph assesment | Measure ulna and radial shortening, tilt palmar | 12 months | 
| DASH Questionnaire | measure life quality | 12 months | 
| VAS (visual analog scale) | patient reported outcome (pain) in scale interval (0 until 10) | 12 months |