THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

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.

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Key information

Conditions

Hip Injuries Wounds and Injuries

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS>90)
Body weight less than 270 lbs
No evidence of post-operative hip subluxation or dislocation
Do not walk with detectable limp
Be able to actively abduct their operated hip against gravity without difficulty
Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms

Exclusion criteria

Pregnant, lactating or females not using reliable form of birth control
Patients that do not meet study requirements
Patients unwilling to sign Informed Consent or HIPAA forms

Treatment and study plan

Fluoroscopy surveillance of patients while walking

Radiation

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.

Other names: DePuy Orthopaedics hip implant

Primary outcomes

Kinematics - Swing Phase Separation

Time frame: 6 months post-operatively

Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Kinematics - Stance Phase Separation

Time frame: 6 months post-operative

Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
Kinematics - Overall Separation

Time frame: 6 months post-operative

Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

DePuy Orthopaedics

Registry information

Official study title

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

Acronym: THA

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 17, 2013
Registry last updated: Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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