Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

Surgery Clinical Trial

— PROQUAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02114840
• Other study ID #: PQP-9CH
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2014
• Last updated: April 13, 2016
• Start date: April 2014
• Est. completion date: September 2019

Study information

• Verified date: April 2016
• Source: Universidad de la Frontera
• Contact: Cristian R Correa
• Phone: +56964052740
• Email: cocorrea[@]uc.cl
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Pronator Quadratus
• Radius Fractures
• Surgery
• Volar Plate
• Wrist Fracture,

Intervention

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

Locations

Country	Name	City	State
Chile	Universidad de la Frontera, Hernan Henriquez Aravena Hospital	Temuco	Temuco/IX Region

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de la Frontera	SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA

Country where clinical trial is conducted

Chile, 

References & Publications (15)

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 — View 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. — View Citation

Créteur 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. Review. — View 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/s00256-012-145 — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Ries C, Maier J, Wegmann K, Zhang W, Hohendorff B, Skouras E, Müller 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 ra — View Citation

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. — View Citation

Stuart PR. Pronator quadratus revisited. J Hand Surg Br. 1996 Dec;21(6):714-22. — View 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 — View Citation

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. — View 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/B — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical impact in dairy life	Clinical impact in dairy life with a functional score	Up to 12 month	No
Primary	Pronosupination strength	Pronosupination strength	Up to 12 month	No
Primary	Proprioception	Proprioception	Up to 12 month	No
Secondary	Proprioception evolution after surgery	Proprioception evolution after surgery	Up to 12 month	No
Secondary	Flexor tendon rupture		Up to 12 month	No
Secondary	Infection after surgery	Infection after surgery	Up to 12 month	No
Secondary	Ischaemic time surgery	ischaemic time surgery	Up to 12 month	No
Secondary	Pronosupination strenght evolution		Up to 12 month	No