NCT02114840

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

April 11, 2014

Last Update Submit

April 13, 2016

Conditions

Wrist Fracture,Distal Radius FracturePronator QuadratusVolar PlateSurgery

Outcome Measures

Primary Outcomes (3)

  • Clinical impact in dairy life

    Clinical impact in dairy life with a functional score

    Up to 12 month

  • Pronosupination strength

    Pronosupination strength

    Up to 12 month

  • Proprioception

    Proprioception

    Up to 12 month

Secondary Outcomes (5)

  • Proprioception evolution after surgery

    Up to 12 month

  • Flexor tendon rupture

    Up to 12 month

  • Infection after surgery

    Up to 12 month

  • Ischaemic time surgery

    Up to 12 month

  • Pronosupination strenght evolution

    Up to 12 month

Study Arms (3)

Pronator quadratus preservation

EXPERIMENTAL

Pronator quadratus preservation

Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures

Pronator quadratus non repair

ACTIVE COMPARATOR
Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Pronator quadratus repair after disruption

ACTIVE COMPARATOR
Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures

Interventions

Pronator quadratus preservation after volar plate fixation in wrist fracturesPROCEDURE

Pronator quadratus preservation after volar plate fixation in wrist fractures

Pronator quadratus preservation
Pronator quadratus repair after volar plate fixation in wrist fracturesPROCEDURE

Pronator quadratus repair after volar plate fixation in wrist fractures

Pronator quadratus repair after disruption
Pronator quadratus nonrepair after volar plate fixation in wrist fracturesPROCEDURE

Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Pronator quadratus non repair

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de la Frontera, Hernan Henriquez Aravena Hospital

Temuco, Temuco/IX Region, 4780000, Chile

RECRUITING

Related Publications (15)

  • Tosti R, Ilyas AM. Prospective evaluation of pronator quadratus repair following volar plate fixation of distal radius fractures. J Hand Surg Am. 2013 Sep;38(9):1678-84. doi: 10.1016/j.jhsa.2013.06.006. Epub 2013 Aug 2.

    PMID: 23916193RESULT

  • 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.

    PMID: 23696162RESULT

  • 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.

    PMID: 23435787RESULT

  • 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.

    PMID: 22854257RESULT

  • 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.

    PMID: 22684408RESULT

  • 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.

    PMID: 22664580RESULT

  • 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.

    PMID: 22277707RESULT

  • 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.

    PMID: 22096615RESULT

  • 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.

    PMID: 22067296RESULT

  • 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.

    PMID: 21464735RESULT

  • 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.

    PMID: 20356451RESULT

  • McConkey MO, Schwab TD, Travlos A, Oxland TR, Goetz T. Quantification of pronator quadratus contribution to isometric pronation torque of the forearm. J Hand Surg Am. 2009 Nov;34(9):1612-7. doi: 10.1016/j.jhsa.2009.07.008. Epub 2009 Oct 14.

    PMID: 19833450RESULT

  • 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.

    PMID: 14642509RESULT

  • Stuart PR. Pronator quadratus revisited. J Hand Surg Br. 1996 Dec;21(6):714-22. doi: 10.1016/s0266-7681(96)80175-6.

    PMID: 8982912RESULT

  • Sotereanos DG, McCarthy DM, Towers JD, Britton CA, Herndon JH. The pronator quadratus: a distinct forearm space? J Hand Surg Am. 1995 May;20(3):496-9. doi: 10.1016/S0363-5023(05)80116-9.

    PMID: 7642936RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Cristian R Correa

    Universidad de La Frontera

    STUDY DIRECTOR

  • Eduardo Guzman

    Universidad de La Frontera

    PRINCIPAL INVESTIGATOR

  • Pelayo Arrieta

    Universidad de La Frontera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian R Correa

CONTACT

+56964052740cocorrea@uc.cl

Eduardo Guzman

CONTACT

+56995402286

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Traumatologist/Orthopedic Surgeon

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2014

Study Completion

September 1, 2019

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

CL(1)