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Completed

NCT Number: NCT03154424

Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

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).

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Key information

Conditions

Distal Radius Fracture Arm Injuries Elderly Person Maltreatment Fractures, Bone Multiple Trauma Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External fixation in treatment the distal radius fracture

Procedure

Compare two techniques

Primary outcomes

  1. Grip strenght

    Time frame: 12 months

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

Secondary outcomes

  1. range of wrist motion

    Time frame: 12 months

    use the specific goniometer to measure the arc of movement the wrist

  2. Radiograph assesment

    Time frame: 12 months

    Measure ulna and radial shortening, tilt palmar

  3. DASH Questionnaire

    Time frame: 12 months

    measure life quality

  4. VAS (visual analog scale)

    Time frame: 12 months

    patient reported outcome (pain) in scale interval (0 until 10)

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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