THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Injuries

Intervention / Treatment
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* Radiation: Fluoroscopy surveillance of patients while walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| THA using direct-anterior surgical approach<br>Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking. | Radiation: Fluoroscopy surveillance of patients while walking<br>* 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.<br>* Other names: DePuy Orthopaedics hip implant;|
| THA using anterior-lateral approach<br>Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. | Radiation: Fluoroscopy surveillance of patients while walking<br>* 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.<br>* Other names: DePuy Orthopaedics hip implant;|
| THA using posterior-lateral approach<br>Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. | Radiation: Fluoroscopy surveillance of patients while walking<br>* 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.<br>* Other names: DePuy Orthopaedics hip implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics - Swing Phase Separation | Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance. | 6 months post-operatively | 
| Kinematics - Stance Phase Separation | Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance. | 6 months post-operative | 
| Kinematics - Overall Separation | Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance | 6 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior-lateral, Surgical approach, Direct-anterior, Anterior-lateral, Hip implant, Total Hip Arthroplasty, Total Hip replacement, Hip replacement, Hip prosthesis