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Wrist Fracture,PROQUAPNCT02114840

Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

A study testing Pronator quadratus preservation after volar plate fixation in wrist fractures, Pronator quadratus repair after volar plate fixation in wrist fractures and Pronator quadratus nonrepair after volar plate fixation in wrist fractures in people with Wrist Fracture, and Distal Radius Fracture, run by Universidad de La Frontera at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 15 to 65 years
What is being tested?
Pronator quadratus preservation after volar plate fixation in wrist fractures, Pronator quadratus repair after volar plate fixation in wrist fractures and Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChile
Study dates
Apr 2014to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Functional deficits of contralateral extremity
  • Complications after surgery with motor deficit
  • Disease that can evolve with neuropathy during study time

Trial locations and contacts

1 site in 1 country.

Cristian R Correa contact

+56964052740

cocorrea@uc.cl

Eduardo Guzman contact

+56995402286

Chile1 site, 1 recruiting

  • Universidad de la Frontera, Hernan Henriquez Aravena Hospital

    Temuco, Temuco/IX Region, 4780000

    Silvia Ancan, Secretary, +56452325760

    Eduardo Guzman

    Recruiting

Other trials in Chile

About this study

Official title: 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

Being tested
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
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pronator quadratus preservation after volar plate fixation in wrist fracturesProcedure or surgery

    Pronator quadratus preservation after volar plate fixation in wrist fractures

  • Pronator quadratus repair after volar plate fixation in wrist fracturesProcedure or surgery

    Pronator quadratus repair after volar plate fixation in wrist fractures

  • Pronator quadratus nonrepair after volar plate fixation in wrist fracturesProcedure or surgery

    Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Study groups in NCT02114840
Study groupRoleWhat they receive
Pronator quadratus preservationExperimentalPronator quadratus preservation
Receives: Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures
Pronator quadratus non repairActive comparatorNot described
Receives: Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures
Pronator quadratus repair after disruptionActive comparatorNot described
Receives: Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical impact in dairy life

    Clinical impact in dairy life with a functional score

    Measured: Up to 12 month

  2. Pronosupination strength

    Pronosupination strength

    Measured: Up to 12 month

  3. Proprioception

    Proprioception

    Measured: Up to 12 month

Secondary outcomes (5)

  1. Proprioception evolution after surgery

    Proprioception evolution after surgery

    Measured: Up to 12 month

  2. Flexor tendon rupture

    Measured: Up to 12 month

  3. Infection after surgery

    Infection after surgery

    Measured: Up to 12 month

  4. Ischaemic time surgery

    ischaemic time surgery

    Measured: Up to 12 month

  5. Pronosupination strenght evolution

    Measured: Up to 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2014
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114840
Sponsor's protocol ID
PQP-9CH
Acronym
PROQUAP
Status last verified
Apr 2016
First submitted
11 Apr 2014
Last updated
15 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 23916193

  • 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.

    PubMed 23696162

  • 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.

    PubMed 23435787

  • 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.

    PubMed 22854257

  • 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.

    PubMed 22684408

  • 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.

    PubMed 22664580

  • 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.

    PubMed 22277707

  • 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.

    PubMed 22096615

  • 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.

    PubMed 22067296

  • 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.

    PubMed 21464735

  • 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.

    PubMed 20356451

  • 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.

    PubMed 19833450

  • 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.

    PubMed 14642509

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

    PubMed 8982912

  • 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.

    PubMed 7642936

Questions about this trial

What is this clinical trial studying?

A study testing Pronator quadratus preservation after volar plate fixation in wrist fractures, Pronator quadratus repair after volar plate fixation in wrist fractures and Pronator quadratus nonrepair after volar plate fixation in wrist fractures in people with Wrist Fracture, and Distal Radius Fracture, run by Universidad de La Frontera at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristian R Correa (+56964052740, cocorrea@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical impact in dairy life (time frame: Up to 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114840, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.

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