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Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients

Sponsor
Faculdade de Medicina do ABC (Other)
Overall Status
Completed
CT.gov ID
NCT03154424
Collaborator
(none)
150
Enrollment
2
Arms
23
Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: External fixation in treatment the distal radius fracture
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Grip strenght [12 months]

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

Secondary Outcome Measures

  1. range of wrist motion [12 months]

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

  2. Radiograph assesment [12 months]

    Measure ulna and radial shortening, tilt palmar

  3. DASH Questionnaire [12 months]

    measure life quality

  4. VAS (visual analog scale) [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Faculdade de Medicina do ABC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcio Aurelio Aita, Affiliated Professor, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT03154424
Other Study ID Numbers:
  • 32925713.9.0000.0082
First Posted:
May 16, 2017
Last Update Posted:
May 16, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Multiple Trauma

Study Results

No Results Posted as of May 16, 2017