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THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

The University of Tennessee, Knoxville logo

The University of Tennessee, Knoxville

Status

Completed

Conditions

Hip Injuries

Treatments

Radiation: Fluoroscopy surveillance of patients while walking

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01833481
R01 1373 452 (Other Identifier)
12009
13-0372 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

THA using direct-anterior surgical approach
Description:
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Treatment:
Radiation: Fluoroscopy surveillance of patients while walking
THA using anterior-lateral approach
Description:
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Treatment:
Radiation: Fluoroscopy surveillance of patients while walking
THA using posterior-lateral approach
Description:
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Treatment:
Radiation: Fluoroscopy surveillance of patients while walking

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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