Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Not Applicable

Completed

• Conditions: Distal Radius Fracture; Elderly Person Maltreatment; Multiple Trauma
• Interventions: Procedure: External fixation in treatment the distal radius fracture

• Registration Number: NCT03154424
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06-01
• Status Verified: 2017-05
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 ).

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Exclusion Criteria

• ongoing chemo or radiotherapy,
• mental illness,
• alcohol abuse.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonbridging (tested group)	External fixation in treatment the distal radius fracture	External fixation in treatment the distal radius fracture improve grip strength?
Bridging (control group)	External fixation in treatment the distal radius fracture	External fixation in treatment the distal radius fracture

Primary Outcome Measures

Name	Time	Method
Grip strenght	12 months	use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist

Secondary Outcome Measures

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