Clinical trial NCT01833481: THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
Official title: In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Injuries
Keywords: Surgical approach
Direct-anterior
Anterior-lateral
Posterior-lateral
Hip implant
Total Hip Arthroplasty
Total Hip replacement
Hip replacement
Hip prosthesis
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2013-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Kinematics - Swing Phase Separation
timeFrame: 6 months post-operatively
measure: Kinematics - Stance Phase Separation
timeFrame: 6 months post-operative
measure: Kinematics - Overall Separation
timeFrame: 6 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Center
state: Maryland
city: Renton
country: United States
facility: Valley Orthopedic Associates ASC
state: Washington
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: The University of Tennessee
name: Richard D Komistek, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Tennessee
name: Adrija Sharma, Ph D
role: PRINCIPAL_INVESTIGATOR
References: