Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

Ultrasound Clinical Trial

Official title:

Is Ultrasound Valid in Distal Radius Fixation With a Volar Plate?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554472
• Other study ID #: IIBSP-ECO-2019-86
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 10, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures
• Ultrasound

Intervention

Diagnostic Test:
• Intraoperative ultrasound
During the surgery, the standard AP and lateral x-rays will be performed. Additional projections (lateral 30 degrees tilt, and dorsal tangential view) will also be registered. Finally an intraoperative ultrasound of the wrist extensor tendons will be taken, checking the compartments individually in order to detect invasion of the dorsal cortex by the screws. In case of no protrusion, the patient will be registered as a correct fixation. Otherwise, it will be specified which position of the plate and which compartment the screw/s protrude. A screw with a correct measurement will then be replaced and implanted and recorded as a measurement error.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. — View Citation

Jupiter JB, Fernandez DL. Complications following distal radial fractures. Instr Course Lect. 2002;51:203-19. Review. — View 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. Review. — View 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 Pen — View Citation

Thorninger R, Madsen ML, Wæver D, Borris LC, Rölfing 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screw protrusion	Perform an ultrasound of each dorsal compartment of the operated wrist	Intraoperative
Secondary	Surgical time	Measure the additional surgical time involved in ultrasound view	Intraoperative