Clinical trial NCT04554472: Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Official title: Is Ultrasound Valid in Distal Radius Fixation With a Volar Plate?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Ultrasound
Keywords: Distal radius volar fixation
Intraoperative ultrasound
screw protrusion detection
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a distal radius fracture with a surgical indication

Brief summary: Distal radius fracture is a common injury with a high percentage of surgical treatment. In the last decades, volar plate fixation has been the treatment of choice. However, complication rates range between 6% and 50% according to the different study groups. One of the main complications is due to errors in screw measurement given the particular anatomy of the distal radius.

Numerous views in addition to the standard ones have been described in order to increase the specificity and sensitivity in the detection of poorly implanted screws. In the absence of a radiological projection superior to another, we believe that the use of intraoperative ultrasound can provide a non-invasive and quick revision element that avoids scope time for both: the patient and the surgical team.

Detailed description: Patients will be recruited in a sequential mode after signing the usual informed consent (IC) as well as the consent to accept participation in the study.

The intervention will be carried out as usual and, once the radiological checks have been carried out, an ultrasound of the wrist extensor compartments will be performed. Compartments will be studied individually in order to detect invasion of the dorsal cortex by the screws.

All surgeries will be performed only by members of the upper limb trauma team or hand surgery unit.

Postoperative follow-up will be the standard one prior to the present study.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Both sexes
* Surgical criteria distal radius fracture.
* Patients with sufficient understanding capacity to read and understand an informed consent.

Exclusion Criteria:

* Patients with a history of any type of surgical intervention on the same limb distal to the elbow.

Primary outcomes:
measure: Screw protrusion
timeFrame: Intraoperative
Secondary outcomes:
measure: Surgical time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
name: Alvaro Toro-Aguilera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
citation: Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.
citation: Jupiter JB, Fernandez DL. Complications following distal radial fractures. Instr Course Lect. 2002;51:203-19. No abstract available.
citation: Stoops TK, Santoni BG, Clark NM, Bauer AA, Shoji C, Schwartz-Fernandes F. Sensitivity and Specificity of Skyline and Carpal Shoot-Through Fluoroscopic Views of Volar Plate Fixation of the Distal Radius: A Cadaveric Investigation of Dorsal Cortex Screw Penetration. Hand (N Y). 2017 Nov;12(6):551-556. doi: 10.1177/1558944716677336. Epub 2016 Nov 1.
citation: Joseph SJ, Harvey JN. The dorsal horizon view: detecting screw protrusion at the distal radius. J Hand Surg Am. 2011 Oct;36(10):1691-3. doi: 10.1016/j.jhsa.2011.07.020. Epub 2011 Aug 23.
citation: Balfour GW. Using Ultrasound to Prevent Screw Penetration. J Hand Surg Am. 2016 Mar;41(3):453-6. doi: 10.1016/j.jhsa.2015.12.020. Epub 2016 Jan 21.
citation: Bergsma M, Denk K, Doornberg JN, van den Bekerom MPJ, Kerkhoffs GMMJ, Jaarsma RL, Obdeijn MC. Volar Plating: Imaging Modalities for the Detection of Screw Penetration. J Wrist Surg. 2019 Dec;8(6):520-530. doi: 10.1055/s-0039-1681026. Epub 2019 Mar 5.
citation: Thorninger R, Madsen ML, Waever D, Borris LC, Rolfing JHD. Complications of volar locking plating of distal radius fractures in 576 patients with 3.2 years follow-up. Injury. 2017 Jun;48(6):1104-1109. doi: 10.1016/j.injury.2017.03.008. Epub 2017 Mar 10.