Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03154424

Enrollment

150

Registered

2017-05-16

Start date

2015-06-01

Completion date

2017-05-01

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture, Elderly Person Maltreatment, Multiple Trauma

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.

Interventions

PROCEDUREExternal fixation in treatment the distal radius fracture

Compare two techniques

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

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.

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Grip strenght	12 months	use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026