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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

Tracking Information
First Submitted Date  ICMJE April 11, 2014
First Posted Date  ICMJE April 15, 2014
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Clinical impact in dairy life [ Time Frame: Up to 12 month ]
    Clinical impact in dairy life with a functional score
  • Pronosupination strength [ Time Frame: Up to 12 month ]
    Pronosupination strength
  • Proprioception [ Time Frame: Up to 12 month ]
    Proprioception
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02114840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Proprioception evolution after surgery [ Time Frame: Up to 12 month ]
    Proprioception evolution after surgery
  • Flexor tendon rupture [ Time Frame: Up to 12 month ]
  • Infection after surgery [ Time Frame: Up to 12 month ]
    Infection after surgery
  • Ischaemic time surgery [ Time Frame: Up to 12 month ]
    ischaemic time surgery
  • Pronosupination strenght evolution [ Time Frame: Up to 12 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pronator Quadratus Preservation Following Volar Plate Fixation. RCT
Official Title  ICMJE Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial
Brief Summary The purpose of this study is to determine pronator quadrutus preservation have clinical impact following volar plate fixation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Wrist Fracture,
  • Distal Radius Fracture
  • Pronator Quadratus
  • Volar Plate
  • Surgery
Intervention  ICMJE
  • Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures
    Pronator quadratus preservation after volar plate fixation in wrist fractures
  • Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures
    Pronator quadratus repair after volar plate fixation in wrist fractures
  • Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures
    Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Study Arms  ICMJE
  • Experimental: Pronator quadratus preservation
    Pronator quadratus preservation
    Intervention: Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures
  • Active Comparator: Pronator quadratus non repair
    Intervention: Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures
  • Active Comparator: Pronator quadratus repair after disruption
    Intervention: Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2016)
150
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2014)
270
Estimated Study Completion Date  ICMJE September 2019
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02114840
Other Study ID Numbers  ICMJE PQP-9CH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Cristian Ricardo Correa Valencia, Universidad de la Frontera
Study Sponsor  ICMJE Universidad de la Frontera
Collaborators  ICMJE SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA
Investigators  ICMJE
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
PRS Account Universidad de la Frontera
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP