Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

NCT ID: NCT02114840

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrist Fracture, Distal Radius Fracture Pronator Quadratus Volar Plate Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pronator quadratus preservation

Pronator quadratus preservation

Group Type EXPERIMENTAL

Pronator quadratus preservation after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Pronator quadratus preservation after volar plate fixation in wrist fractures

Pronator quadratus non repair

Group Type ACTIVE_COMPARATOR

Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Pronator quadratus repair after disruption

Group Type ACTIVE_COMPARATOR

Pronator quadratus repair after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Pronator quadratus repair after volar plate fixation in wrist fractures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pronator quadratus preservation after volar plate fixation in wrist fractures

Pronator quadratus preservation after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Pronator quadratus repair after volar plate fixation in wrist fractures

Pronator quadratus repair after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Pronator quadratus nonrepair after volar plate fixation in wrist fractures

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fractures of distal radius with instability (Aofoundation.org)
* Age between 15-75 aƱos
* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA

UNKNOWN

Sponsor Role collaborator

Universidad de La Frontera

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cristian Ricardo Correa Valencia

MD, Traumatologist/Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristian R Correa

Role: STUDY_DIRECTOR

Universidad de La Frontera

Eduardo Guzman

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Pelayo Arrieta

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de la Frontera, Hernan Henriquez Aravena Hospital

Temuco, Temuco/IX Region, Chile

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Chile

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristian R Correa

Role: CONTACT

+56964052740

Eduardo Guzman

Role: CONTACT

+56995402286

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Silvia Ancan, Secretary

Role: primary

+56452325760

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23916193 (View on PubMed)

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.

Reference Type RESULT
PMID: 23696162 (View on PubMed)

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.

Reference Type RESULT
PMID: 23435787 (View on PubMed)

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.

Reference Type RESULT
PMID: 22854257 (View on PubMed)

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.

Reference Type RESULT
PMID: 22684408 (View on PubMed)

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.

Reference Type RESULT
PMID: 22664580 (View on PubMed)

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.

Reference Type RESULT
PMID: 22277707 (View on PubMed)

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.

Reference Type RESULT
PMID: 22096615 (View on PubMed)

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.

Reference Type RESULT
PMID: 22067296 (View on PubMed)

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.

Reference Type RESULT
PMID: 21464735 (View on PubMed)

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.

Reference Type RESULT
PMID: 20356451 (View on PubMed)

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.

Reference Type RESULT
PMID: 19833450 (View on PubMed)

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.

Reference Type RESULT
PMID: 14642509 (View on PubMed)

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

Reference Type RESULT
PMID: 8982912 (View on PubMed)

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.

Reference Type RESULT
PMID: 7642936 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PQP-9CH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.