Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

NCT04554472 | Completed DMC

• 1 other identifier: IIBSP-ECO-2019-86
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture; Ultrasound

Keywords

Distal radius volar fixation; Intraoperative ultrasound; screw protrusion detection

Outcome Measures

Primary Outcomes (1)

• Screw protrusion

  Perform an ultrasound of each dorsal compartment of the operated wrist

  Intraoperative

Secondary Outcomes (1)

• Surgical time

  Intraoperative

Study Arms (1)

Study group

Patients with a distal radius fracture requiring surgery who meet the exclusion and inclusion criteria

Diagnostic Test: Intraoperative ultrasound

Interventions

Intraoperative ultrasound DIAGNOSTIC_TEST

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a distal radius fracture with a surgical indication

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Location

Related Publications (8)

• 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.

  PMID: 11561245 RESULT

• 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.

  PMID: 22554654 RESULT

• Jupiter JB, Fernandez DL. Complications following distal radial fractures. Instr Course Lect. 2002;51:203-19. No abstract available.

  PMID: 12064104 RESULT

• 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.

  PMID: 29091485 RESULT

• 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.

  PMID: 21864994 RESULT

• 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.

  PMID: 26803568 RESULT

• 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.

  PMID: 31815069 RESULT

• 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.

  PMID: 28336098 RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Alvaro Toro-Aguilera, MD, PhD

  Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: September 22, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 10, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)