Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554472
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2020-09-14
Brief Title:
Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Is Ultrasound Valid in Distal Radius Fixation With a Volar Plate
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None