Clinical Trial: Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Faculdade de Medicina do ABC

Current Primary Outcome: Grip strenght [ Time Frame: 12 months ]

use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Faculdade de Medicina do ABC

Dates:
Date Received: May 11, 2017
Date Started: June 1, 2015
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017