Clinical trial NCT03371030: Role of the Pronator Quadratus in Distal Radius Fractures
Official title: Role of the Pronator Quadratus in Vascularity and Stabilisation in Distal Radius Fractures After Osteosynthesis: Clinical and Anatomical Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius; Fracture, Lower or Distal End
Keywords: distal radius fractures
pronator quadratus
osteosynthesis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2017-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The skin, the bones, and most muscles received branches from the source arteries of at least two angiosomes, thus revealing one of the important anastomotic pathways by which the circulation is reconstituted in those cases where a source artery is interrupted by disease or trauma.

There are numerous metaphyseal-epiphyseal branches arise within the pronator quadratus and the anterior interosseous artery and course towards the distal radius. These branches may be fundamental to the healing of the distal radius fractures and make nonunion a rare complication. The aim of this study is the evaluation of the role of the pronator quadratus muscle and its repair in volar approach in distal radius fractures treated with plate fixation.

Detailed description: Nonunion is an extremely rare complication in distal radius fractures and is most likely to occur in patients with conditions such as diabetes, peripheral vascular disease, or alcoholism. Diagnosis of nonunion is based on the absence of radiographic signs of union at 6 months. Treatment should be individualized but options are reconstructive procedures or wrist arthrodesis. In volar plating and often by the fracture injury itself, the complete pronator quadratus is stripped off the volar radius. Thus, the intraosseous collateral circulation must be sufficient for clinical healing. Any operative approach to the distal radius fracture should not compromise both volar radial and the dorsoulnar arteries.

While the branches to the pronator quadratus must be sacrificed in a palmar approach, the distal perforator can and should be spared. This is true even in the flexor carpi radialis extended approach. In distal radius fractures, when the normal outward flow of blood through the cortex is blocked, the periosteal arterioles have more ability than medullary arterioles to function and proliferate.

Eligibility criteria: Inclusion Criteria:

* Distal radius fractures with intra-articular fragment, comminuted or displaced fracture
* Adults between 18- 90 years old

Exclusion Criteria:

* Children
* Non displaced distal radius fractures treated with immobilization.
* Adults older than 90 years old

Primary outcomes:
measure: Fracture consolidation
timeFrame: 3 months
Secondary outcomes:
measure: Clinical stability
timeFrame: 3 months
measure: Radiological stability
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Claudia Lamas, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haerle M, Schaller HE, Mathoulin C. Vascular anatomy of the palmar surfaces of the distal radius and ulna: its relevance to pedicled bone grafts at the distal palmar forearm. J Hand Surg Br. 2003 Apr;28(2):131-6. doi: 10.1016/s0266-7681(02)00279-6.
citation: Inoue Y, Taylor GI. The angiosomes of the forearm: anatomic study and clinical implications. Plast Reconstr Surg. 1996 Aug;98(2):195-210. doi: 10.1097/00006534-199608000-00001.
citation: Orbay J, Badia A, Khoury RK, Gonzalez E, Indriago I. Volar fixed-angle fixation of distal radius fractures: the DVR plate. Tech Hand Up Extrem Surg. 2004 Sep;8(3):142-8. doi: 10.1097/01.bth.0000126570.82826.0a.
citation: Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14. doi: 10.1016/S0363-5023(05)80136-4.
citation: Huang HK, Wang JP, Chang MC. Repair of Pronator Quadratus With Partial Muscle Split and Distal Transfer for Volar Plating of Distal Radius Fractures. J Hand Surg Am. 2017 Nov;42(11):935.e1-935.e5. doi: 10.1016/j.jhsa.2017.08.018.
citation: Lamas C, Llusa M, Mendez A, Proubasta I, Carrera A, Forcada P. Intraosseous vascularity of the distal radius: anatomy and clinical implications in distal radius fractures. Hand (N Y). 2009 Dec;4(4):418-23. doi: 10.1007/s11552-009-9204-9. Epub 2009 May 28.