Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

ABC Foundation (FUABC)

Status: Completed

Conditions: Elderly Person Maltreatment; Multiple Trauma; Distal Radius Fracture

Treatments: Procedure: External fixation in treatment the distal radius fracture

Study type: Interventional

Funder types: Other

Identifiers

NCT03154424

32925713.9.0000.0082

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Bridging (control group)

Placebo Comparator group

Description:

External fixation in treatment the distal radius fracture

Treatment:

Procedure: External fixation in treatment the distal radius fracture

Nonbridging (tested group)

Active Comparator group

Description:

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

Treatment:

Procedure: External fixation in treatment the distal radius fracture