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Clinical Trials/NCT04554472
NCT04554472
Completed
Not Applicable

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country30 target enrollmentSeptember 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
30
Locations
1
Primary Endpoint
Screw protrusion
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 22, 2020
End Date
October 10, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Screw protrusion

Time Frame: Intraoperative

Perform an ultrasound of each dorsal compartment of the operated wrist

Secondary Outcomes

  • Surgical time(Intraoperative)

Study Sites (1)

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