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

April 13, 2016 updated by: Cristian Ricardo Correa Valencia, Universidad de La Frontera

Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Temuco/IX Region
      • Temuco, Temuco/IX Region, Chile, 4780000
        • Recruiting
        • Universidad de la Frontera, Hernan Henriquez Aravena Hospital
        • Contact:
          • Silvia Ancan, Secretary
          • Phone Number: +56452325760
        • Principal Investigator:
          • Eduardo Guzman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical impact in dairy life
Time Frame: Up to 12 month
Clinical impact in dairy life with a functional score
Up to 12 month
Pronosupination strength
Time Frame: Up to 12 month
Pronosupination strength
Up to 12 month
Proprioception
Time Frame: Up to 12 month
Proprioception
Up to 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proprioception evolution after surgery
Time Frame: Up to 12 month
Proprioception evolution after surgery
Up to 12 month
Flexor tendon rupture
Time Frame: Up to 12 month
Up to 12 month
Infection after surgery
Time Frame: Up to 12 month
Infection after surgery
Up to 12 month
Ischaemic time surgery
Time Frame: Up to 12 month
ischaemic time surgery
Up to 12 month
Pronosupination strenght evolution
Time Frame: Up to 12 month
Up to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de La Frontera

Collaborators

SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PQP-9CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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