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THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The University of Tennessee Knoxville
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
The University of Tennessee Knoxville
ClinicalTrials.gov Identifier:
NCT01833481
First received: April 11, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hip Injuries
Radiation: Fluoroscopy surveillance of patients while walking

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches

Resource links provided by NLM:


Further study details as provided by The University of Tennessee Knoxville:

Primary Outcome Measures:
  • Kinematics - swing phase separation [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    Determine amount of in vivo 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 ] [ Designated as safety issue: No ]
    Determine amount of hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.

  • Kinematics - overall separation [ Time Frame: 6 months post-operative ] [ Designated as safety issue: No ]
    Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
THA using 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 Name: 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 Name: 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 Name: DePuy Orthopaedics hip implant

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833481

Contacts
Contact: Richard D Komistek, Ph D 865-974-4159 rkomiste@utk.edu
Contact: Rebecca R Robertson, BA 865-974-2093 rrober28@utk.edu

Locations
United States, Maryland
University of Maryland St. Joseph Medical Center Recruiting
Towson, Maryland, United States, 21201
Contact: David F Dalury, MD    410-337-7900 ext 1221    ddalury@towsonortho.com   
Contact: Danielle Chapman, RT(R)    (410) 337-7900 ext 1221    dchapman@towsonortho.com   
Principal Investigator: David F Dalury, MD         
United States, Washington
Valley Orthopedic Associates ASC Completed
Renton, Washington, United States, 90855
Canada, Ontario
University Hospital Completed
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
The University of Tennessee Knoxville
DePuy Orthopaedics
Investigators
Principal Investigator: Richard D Komistek, Ph D The University of Tennessee
Principal Investigator: Adrija Sharma, Ph D The University of Tennessee
  More Information

No publications provided

Responsible Party: The University of Tennessee Knoxville
ClinicalTrials.gov Identifier: NCT01833481     History of Changes
Other Study ID Numbers: 12009, R01 1373 452, 13-0372
Study First Received: April 11, 2013
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by The University of Tennessee Knoxville:
Surgical approach
Anterior
Anterior-lateral
Posterior-lateral
Hip implant
Total Hip Arthroplasty
Total Hip replacement
Hip replacement
Hip prosthesis

Additional relevant MeSH terms:
Hip Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014