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Trial record 88 of 770 for:    region | Chile

Pronator Quadratus Preservation Following Volar Plate Fixation. RCT (PROQUAP)

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ClinicalTrials.gov Identifier: NCT02114840
Recruitment Status : Unknown
Verified April 2016 by Cristian Ricardo Correa Valencia, Universidad de la Frontera.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA
Information provided by (Responsible Party):
Cristian Ricardo Correa Valencia, Universidad de la Frontera

Brief Summary:
The purpose of this study is to determine pronator quadrutus preservation have clinical impact following volar plate fixation

Condition or disease Intervention/treatment Phase
Wrist Fracture, Distal Radius Fracture Pronator Quadratus Volar Plate Surgery Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial
Study Start Date : April 2014
Actual Primary Completion Date : April 2014
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Pronator quadratus preservation
Pronator quadratus preservation
Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures
Pronator quadratus preservation after volar plate fixation in wrist fractures

Active Comparator: Pronator quadratus non repair Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Active Comparator: Pronator quadratus repair after disruption Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures
Pronator quadratus repair after volar plate fixation in wrist fractures




Primary Outcome Measures :
  1. Clinical impact in dairy life [ Time Frame: Up to 12 month ]
    Clinical impact in dairy life with a functional score

  2. Pronosupination strength [ Time Frame: Up to 12 month ]
    Pronosupination strength

  3. Proprioception [ Time Frame: Up to 12 month ]
    Proprioception


Secondary Outcome Measures :
  1. Proprioception evolution after surgery [ Time Frame: Up to 12 month ]
    Proprioception evolution after surgery

  2. Flexor tendon rupture [ Time Frame: Up to 12 month ]
  3. Infection after surgery [ Time Frame: Up to 12 month ]
    Infection after surgery

  4. Ischaemic time surgery [ Time Frame: Up to 12 month ]
    ischaemic time surgery

  5. Pronosupination strenght evolution [ Time Frame: Up to 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fractures of distal radius with instability (Aofoundation.org)
  • Age between 15-75 años
  • Informed consent approval for ethical comitte

Exclusion Criteria:

  • Previos surgery of the hand, wrist or forearm
  • Inflammatory arthropathy
  • Carpal tunel syndrome
  • Sensory or mixed neuropathy
  • Bilater wrist fracture
  • Functional deficits of ipsilateral extremity
  • Functional deficits of contralateral extremity
  • Complications after surgery with motor deficit
  • Disease that can evolve with neuropathy during study time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114840


Contacts
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Contact: Cristian R Correa +56964052740 cocorrea@uc.cl
Contact: Eduardo Guzman +56995402286

Locations
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Chile
Universidad de la Frontera, Hernan Henriquez Aravena Hospital Recruiting
Temuco, Temuco/IX Region, Chile, 4780000
Contact: Silvia Ancan, Secretary    +56452325760      
Principal Investigator: Eduardo Guzman         
Sponsors and Collaborators
Universidad de la Frontera
SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA
Investigators
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Study Director: Cristian R Correa Universidad de la Frontera
Principal Investigator: Eduardo Guzman Universidad de la Frontera
Principal Investigator: Pelayo Arrieta Universidad de la Frontera

Publications of Results:

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Responsible Party: Cristian Ricardo Correa Valencia, MD, Traumatologist/Orthopedic Surgeon, Universidad de la Frontera
ClinicalTrials.gov Identifier: NCT02114840     History of Changes
Other Study ID Numbers: PQP-9CH
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries