Completed

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

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What is being collected

Radiation Data

+ radiation Data

+ radiation Data

Collected from past medical records and data - Retrospective
Radiation
Who is being recruted

Wounds and Injuries

+ Hip Injuries

From 40 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: June 2013
See protocol details

Summary

Principal SponsorThe University of Tennessee, Knoxville
Last updated: October 10, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01833481
Principal SponsorThe University of Tennessee, Knoxville
Last updated: October 10, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Wounds and InjuriesHip Injuries

Criteria

6 inclusion criteria required to participate
Be able to actively abduct their operated hip against gravity without difficulty

Body weight less than 270 lbs

Do not walk with detectable limp

Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms

Show More Criteria

3 exclusion criteria prevent from participating
Patients that do not meet study requirements

Patients unwilling to sign Informed Consent or HIPAA forms

Pregnant, lactating or females not using reliable form of birth control

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

University of Maryland St. Joseph Medical Center

Towson, United StatesOpen University of Maryland St. Joseph Medical Center in Google Maps

Valley Orthopedic Associates ASC

Renton, United States

University Hospital

London, Canada
Completed3 Study Centers