CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Fluoroscopy surveillance of patients while walkingradiation
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01833481
NCT01833481N/ACompleted

In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches

The University of Tennessee, Knoxville·observational·Posted Apr 17, 2013·Updated Oct 10, 2019

In Brief

An observational study evaluating Fluoroscopy surveillance of patients while walking for Hip Injuries. Completed, enrolled 30 participants across 3 sites in 2 countries.

Detailed Summary

In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches. It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation. All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHip Injuries
CountriesCanada, United States
CollaboratorsDePuy Orthopaedics

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2013
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.2 years ago

Interventions

Fluoroscopy surveillance of patients while walkingradiation

While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.