Clinical Trial: THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: The University of Tennessee, Knoxville

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • In vivo fluoroscopic evaluation of implanted hip. [ Time Frame: 6 months post-operatively ]
    Determine the effects that three different surgical techniques have on weight-bearing in vivo motion of the hip joint while subjects perform a gait (normal walking) activity under fluoroscopic surveillance.
  • Sound/Vibration correlation [ Time Frame: 6 months post-operatively ]
    Correlate in vivo fluoroscopy data with vibrations/sounds detected using the data acquisition (DAQ) system. The sound data acquisition will be collected simultaneously as the fluoroscopy evaluation.


Current Secondary Outcome:

Original Secondary Outcome: Classify sounds [ Time Frame: 6 months post-operatively ]

Classify sounds acquired from sound/vibration data that occur between hip implant components to determine if a specific surgical approach leads to a greater or lesser amount of hip separation and/or sound.


Information By: The University of Tennessee, Knoxville

Dates:
Date Received: April 11, 2013
Date Started: June 2013
Date Completion:
Last Updated: October 31, 2014
Last Verified: October 2014