NCT03154424

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 11, 2017

Last Update Submit

May 12, 2017

Conditions

Distal Radius FractureMultiple TraumaElderly Person Maltreatment

Outcome Measures

Primary Outcomes (1)

  • Grip strenght

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

    12 months

Secondary Outcomes (4)

  • range of wrist motion

    12 months

  • Radiograph assesment

    12 months

  • DASH Questionnaire

    12 months

  • VAS (visual analog scale)

    12 months

Study Arms (2)

Bridging (control group)

PLACEBO COMPARATOR

External fixation in treatment the distal radius fracture

Procedure: External fixation in treatment the distal radius fracture

Nonbridging (tested group)

ACTIVE COMPARATOR

External fixation in treatment the distal radius fracture improve grip strength?

Procedure: External fixation in treatment the distal radius fracture

Interventions

External fixation in treatment the distal radius fracturePROCEDURE

Compare two techniques

Bridging (control group)Nonbridging (tested group)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ).

You may not qualify if:

  • ongoing chemo or radiotherapy,
  • mental illness,
  • alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist FracturesMultiple Trauma

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Professor

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share