Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154424
• Other study ID #: 32925713.9.0000.0082
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 12, 2017
• Start date: June 1, 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2017
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Elderly Person Maltreatment
• Fractures, Bone
• Multiple Trauma
• Radius Fractures

Intervention

Procedure:
• External fixation in treatment the distal radius fracture
Compare two techniques

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Outcome

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