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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Trauma; Distal Radius Fracture; Elderly Person Maltreatment
• Intervention / Treatment: Procedure: External fixation in treatment the distal radius fracture

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Multiple Trauma; Radius Fractures
• Other Study ID Numbers: 32925713.9.0000.0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No