Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

Completed

• Conditions: Ultrasound; Distal Radius Fracture
• Interventions: Diagnostic Test: Intraoperative ultrasound

• Registration Number: NCT04554472
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2020-09-22
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Intraoperative ultrasound	Patients with a distal radius fracture requiring surgery who meet the exclusion and inclusion criteria

Primary Outcome Measures

Name	Time	Method
Screw protrusion	Intraoperative	Perform an ultrasound of each dorsal compartment of the operated wrist

Secondary Outcome Measures

Name	Time	Method
Surgical time	Intraoperative	Measure the additional surgical time involved in ultrasound view

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain