NCT04554472

Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture
• Ultrasound

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-10-01
• Completion: 2022-10-10
• First posted: 2020-09-18
• Last updated: 2022-10-12

Locations

1 site across 1 country: Spain