41
Participants
Start Date
March 9, 2022
Primary Completion Date
March 31, 2023
Study Completion Date
August 31, 2023
Ultrasound Scan
Within 90 days before the revision surgery, a calibrated examiner will ultrasonically scan the implants. The ultrasound device has been validated for its usability and design on human subjects in our recent clinical study (the University of Michigan Institutional Review Board under the number HUM00139630 and was registered with the National Institutes of Health U.S. National Library of Medicine database for clinical trials (clinicaltrials.gov) under the following identifier: NCT03558282) Coupling will be achieved with commercially available sterilized US gel (Sterile Aquasonic, Fairfield, NJ). The US probe will be mounted on an adjustable arm attached to a fixed stand. The probe is navigated by a calibrated examiner at the implant of interest and then will execute a total ±5 mm linear mesio-distal and coronal-apical translations to create 3D cross-sectional and transverse volumes, respectively and stored as an imageframe series, i.e., a DICOM format cineloop.
University of Michigan, Ann Arbor
National Institutes of Health (NIH)
NIH
University of Michigan
OTHER