THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches

NCT01833481 | Completed Results

• 3 other identifiers: 12009R01 1373 45213-0372
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hip Injuries

Keywords

Surgical approach; Direct-anterior; Anterior-lateral; Posterior-lateral; Hip implant; Total Hip Arthroplasty; Total Hip replacement; Hip replacement; Hip prosthesis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Kinematics - Overall Separation

  Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance

  6 months post-operative

Study Arms (3)

THA using direct-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

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

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

Interventions

Fluoroscopy surveillance of patients while walking RADIATION

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.

Also known as: DePuy Orthopaedics hip implant

THA using anterior-lateral approach; THA using direct-anterior surgical approach; THA using posterior-lateral approach

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• DePuy Orthopaedics: collaborator

Study Sites (3)

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21201, United States

Location

Valley Orthopedic Associates ASC

Renton, Washington, 90855, United States

Location

University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. Richard D. Komistek
• Organization: University of Tennessee

rkomiste@utk.edu

8659742093

Study Officials

• Richard D Komistek, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

• Adrija Sharma, Ph D

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 17, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 10, 2019
• Results First Posted: November 6, 2014

Record last verified: 2019-10

Locations

US (2); CA (1)