Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

October 10, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a distal radius fracture with a surgical indication

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients with a distal radius fracture requiring surgery who meet the exclusion and inclusion criteria
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screw protrusion
Time Frame: Intraoperative
Perform an ultrasound of each dorsal compartment of the operated wrist
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time
Time Frame: Intraoperative
Measure the additional surgical time involved in ultrasound view
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alvaro Toro-Aguilera, MD, PhD, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ECO-2019-86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be extracted and published collectively with respect to:

  1. Demographic data: number of participants, sex distribution, age distribution, fracture complexity distribution, time of surgery
  2. Screw detection rate of each x-ray projection
  3. Screw detection rate of intraoperative ultrasound

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distal Radius Fracture

Clinical Trials on Intraoperative ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe