THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

Hip Injuries Clinical Trial

— THA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833481
• Other study ID #: 12009
• Secondary ID: R01 1373 45213-0
• Status: Completed
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario
United States	Valley Orthopedic Associates ASC	Renton	Washington
United States	University of Maryland St. Joseph Medical Center	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	DePuy Orthopaedics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Kinematics - Overall Separation	Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance	6 months post-operative