Clinical trial NCT02114840: Pronator Quadratus Preservation Following Volar Plate Fixation. RCT
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
Overall status: UNKNOWN
Phase: NA
Conditions: Wrist Fracture,
Distal Radius Fracture
Pronator Quadratus
Volar Plate
Surgery
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
Collaborators: name: SOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIA
First posted: 2014-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Clinical impact in dairy life
timeFrame: Up to 12 month
measure: Pronosupination strength
timeFrame: Up to 12 month
measure: Proprioception
timeFrame: Up to 12 month
Secondary outcomes:
measure: Proprioception evolution after surgery
timeFrame: Up to 12 month
measure: Flexor tendon rupture
timeFrame: Up to 12 month
measure: Infection after surgery
timeFrame: Up to 12 month
measure: Ischaemic time surgery
timeFrame: Up to 12 month
measure: Pronosupination strenght evolution
timeFrame: Up to 12 month
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de la Frontera, Hernan Henriquez Aravena Hospital
state: Temuco/IX Region
Study officials:
affiliation: Universidad de La Frontera
name: Cristian R Correa
role: STUDY_DIRECTOR
affiliation: Universidad de La Frontera
name: Eduardo Guzman
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de La Frontera
name: Pelayo Arrieta
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Stuart PR. Pronator quadratus revisited. J Hand Surg Br. 1996 Dec;21(6):714-22. doi: 10.1016/s0266-7681(96)80175-6.
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. doi: 10.1016/S0363-5023(05)80116-9.