THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches (THA)

In Vivo Determination of THA Kinematics and Sound for Subject 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.

Study Overview

• Status: Completed
• Conditions: Hip Injuries
• Intervention / Treatment: Radiation: Fluoroscopy surveillance of patients while walking

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University Hospital
• United States
  • Maryland
    • Towson, Maryland, United States, 21201
      • University of Maryland St. Joseph Medical Center
  • Washington
    • Renton, Washington, United States, 90855
      • Valley Orthopedic Associates ASC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA.

Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario.

Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
THA using direct-anterior surgical approach; 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; 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
THA using anterior-lateral approach; 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; 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
THA using posterior-lateral approach; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: DePuy Orthopaedics
• Investigators: Principal Investigator: Adrija Sharma, Ph D, The University of Tennessee; Principal Investigator: Richard D Komistek, Ph D, The University of Tennessee

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hip replacement; Hip prosthesis; Total Hip Arthroplasty; Total Hip replacement; Surgical approach; Hip implant; Direct-anterior; Anterior-lateral; Posterior-lateral
• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries
• Other Study ID Numbers: 12009; R01 1373 452 (Other Identifier: University of Tennessee); 13-0372 (Other Identifier: University of Tennessee)