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NCT Number: NCT04554472

Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Ultrasound Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Screw protrusion

    Time frame: Intraoperative

    Perform an ultrasound of each dorsal compartment of the operated wrist

Secondary outcomes

  1. Surgical time

    Time frame: Intraoperative

    Measure the additional surgical time involved in ultrasound view

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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