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

Primary Purpose

Wrist Fracture,, Distal Radius Fracture, Pronator Quadratus

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Pronator quadratus preservation after volar plate fixation in wrist fractures
Pronator quadratus repair after volar plate fixation in wrist fractures
Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Sponsored by
Universidad de La Frontera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Fracture,

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de la Frontera, Hernan Henriquez Aravena HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Pronator quadratus preservation

Pronator quadratus non repair

Pronator quadratus repair after disruption

Arm Description

Pronator quadratus preservation

Outcomes

Primary Outcome Measures

Clinical impact in dairy life
Clinical impact in dairy life with a functional score
Pronosupination strength
Pronosupination strength
Proprioception
Proprioception

Secondary Outcome Measures

Proprioception evolution after surgery
Proprioception evolution after surgery
Flexor tendon rupture
Infection after surgery
Infection after surgery
Ischaemic time surgery
ischaemic time surgery
Pronosupination strenght evolution

Full Information

First Posted
April 11, 2014
Last Updated
April 13, 2016
Sponsor
Universidad de La Frontera
Collaborators
SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA
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1. Study Identification

Unique Protocol Identification Number
NCT02114840
Brief Title
Pronator Quadratus Preservation Following Volar Plate Fixation. RCT
Acronym
PROQUAP
Official Title
Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de La Frontera
Collaborators
SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fracture,, Distal Radius Fracture, Pronator Quadratus, Volar Plate, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pronator quadratus preservation
Arm Type
Experimental
Arm Description
Pronator quadratus preservation
Arm Title
Pronator quadratus non repair
Arm Type
Active Comparator
Arm Title
Pronator quadratus repair after disruption
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Pronator quadratus preservation after volar plate fixation in wrist fractures
Intervention Description
Pronator quadratus preservation after volar plate fixation in wrist fractures
Intervention Type
Procedure
Intervention Name(s)
Pronator quadratus repair after volar plate fixation in wrist fractures
Intervention Description
Pronator quadratus repair after volar plate fixation in wrist fractures
Intervention Type
Procedure
Intervention Name(s)
Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Intervention Description
Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Primary Outcome Measure Information:
Title
Clinical impact in dairy life
Description
Clinical impact in dairy life with a functional score
Time Frame
Up to 12 month
Title
Pronosupination strength
Description
Pronosupination strength
Time Frame
Up to 12 month
Title
Proprioception
Description
Proprioception
Time Frame
Up to 12 month
Secondary Outcome Measure Information:
Title
Proprioception evolution after surgery
Description
Proprioception evolution after surgery
Time Frame
Up to 12 month
Title
Flexor tendon rupture
Time Frame
Up to 12 month
Title
Infection after surgery
Description
Infection after surgery
Time Frame
Up to 12 month
Title
Ischaemic time surgery
Description
ischaemic time surgery
Time Frame
Up to 12 month
Title
Pronosupination strenght evolution
Time Frame
Up to 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristian R Correa
Phone
+56964052740
Email
cocorrea@uc.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Guzman
Phone
+56995402286
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian R Correa
Organizational Affiliation
Universidad de La Frontera
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eduardo Guzman
Organizational Affiliation
Universidad de La Frontera
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pelayo Arrieta
Organizational Affiliation
Universidad de La Frontera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de la Frontera, Hernan Henriquez Aravena Hospital
City
Temuco
State/Province
Temuco/IX Region
ZIP/Postal Code
4780000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Ancan, Secretary
Phone
+56452325760
First Name & Middle Initial & Last Name & Degree
Eduardo Guzman

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23916193
Citation
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Results Reference
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PubMed Identifier
23696162
Citation
Ries C, Maier J, Wegmann K, Zhang W, Hohendorff B, Skouras E, Muller LP, Burkhart KJ. [Anatomic relationship between the pronator quadratus and brachioradialis muscle insertion: implications for repair of the muscle after volar plate fixation of distal radius fractures]. Z Orthop Unfall. 2013 Jun;151(3):272-7. doi: 10.1055/s-0032-1328493. Epub 2013 May 21. German.
Results Reference
result
PubMed Identifier
23435787
Citation
Armangil M, Bezirgan U, Basarir K, Bilen G, Demirtas M, Bilgin SS. The pronator quadratus muscle after plating of distal radius fractures: is the muscle still working? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):335-9. doi: 10.1007/s00590-013-1193-2. Epub 2013 Feb 23.
Results Reference
result
PubMed Identifier
22854257
Citation
Swigart CR, Badon MA, Bruegel VL, Dodds SD. Assessment of pronator quadratus repair integrity following volar plate fixation for distal radius fractures: a prospective clinical cohort study. J Hand Surg Am. 2012 Sep;37(9):1868-73. doi: 10.1016/j.jhsa.2012.06.005. Epub 2012 Jul 31.
Results Reference
result
PubMed Identifier
22684408
Citation
Fallahi F, Jafari H, Jefferson G, Jennings P, Read R. Explorative study of the sensitivity and specificity of the pronator quadratus fat pad sign as a predictor of subtle wrist fractures. Skeletal Radiol. 2013 Feb;42(2):249-53. doi: 10.1007/s00256-012-1451-0. Epub 2012 Jun 9.
Results Reference
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PubMed Identifier
22664580
Citation
Hershman SH, Immerman I, Bechtel C, Lekic N, Paksima N, Egol KA. The effects of pronator quadratus repair on outcomes after volar plating of distal radius fractures. J Orthop Trauma. 2013 Mar;27(3):130-3. doi: 10.1097/BOT.0b013e3182539333.
Results Reference
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PubMed Identifier
22277707
Citation
Creteur V, Madani A, Brasseur JL. Pronator quadratus imaging. Diagn Interv Imaging. 2012 Jan;93(1):22-9. doi: 10.1016/j.diii.2011.10.006. Epub 2011 Dec 13.
Results Reference
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PubMed Identifier
22096615
Citation
Brown EN, Lifchez SD. Flexor pollicis longus tendon rupture after volar plating of a distal radius fracture: pronator quadratus plate coverage may not adequately protect tendons. Eplasty. 2011;11:e43. Epub 2011 Nov 9.
Results Reference
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PubMed Identifier
22067296
Citation
Heidari N, Clement H, Kosuge D, Grechenig W, Tesch NP, Weinberg AM. Is sparing the pronator quadratus muscle possible in volar plating of the distal radius? J Hand Surg Eur Vol. 2012 Jun;37(5):402-6. doi: 10.1177/1753193411424706. Epub 2011 Nov 8.
Results Reference
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PubMed Identifier
21464735
Citation
Zenke Y, Sakai A, Oshige T, Moritani S, Fuse Y, Maehara T, Nakamura T. Clinical results of volar locking plate for distal radius fractures: conventional versus minimally invasive plate osteosynthesis. J Orthop Trauma. 2011 Jul;25(7):425-31. doi: 10.1097/BOT.0b013e3182008c83.
Results Reference
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PubMed Identifier
20356451
Citation
Lucchina S, Fusetti C. Is early hardware removal compulsory after retention of angled drill guides in palmar locking plates? The role of pronator quadratus reconstruction. Chin J Traumatol. 2010 Apr 1;13(2):123-5.
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Citation
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PubMed Identifier
14642509
Citation
Gordon KD, Dunning CE, Johnson JA, King GJ. Influence of the pronator quadratus and supinator muscle load on DRUJ stability. J Hand Surg Am. 2003 Nov;28(6):943-50. doi: 10.1016/s0363-5023(03)00487-8.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

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