THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

NCT ID: NCT02682602

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-03-31

Brief Summary

The objective of this study is to analyze subjects having a normal hip and compare the in vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased hip and then later post-operative to their implanted hip. Ten subjects will have a normal hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be re-analyzed at least six months post-operatively after implantation of a THA.

Conditions

Hip Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diseased Hip

Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.

Computer tomography

Intervention Type: RADIATION

Computer tomography (CT) scan of the hip for creation of bone models.

Fluoroscopy surveillance

Intervention Type: RADIATION

Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.

Normal Hip

Subjects will have a normal hip.

Computer tomography

Intervention Type: RADIATION

Computer tomography (CT) scan of the hip for creation of bone models.

Fluoroscopy surveillance

Intervention Type: RADIATION

Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.

Implanted Group

All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA

DePuy Synthes total hip arthroplasty

Intervention Type: DEVICE

Fluoroscopy surveillance

Intervention Type: RADIATION

Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.

Interventions

DePuy Synthes total hip arthroplasty

Intervention Type: DEVICE

Computer tomography

Computer tomography (CT) scan of the hip for creation of bone models.

Intervention Type: RADIATION

Fluoroscopy surveillance

Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.

Intervention Type: RADIATION

Other Intervention Names

DePuy Synthes Summit/Pinnacle THA; DePuy Synthes Corail/Pinnacle THA

Eligibility Criteria

Inclusion Criteria

• Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.
• Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.
• Patients must be between 40-85 years of age.
• Potential subjects will have a body weight of less than 250 lbs.
• Participants must have Body Mass Index (BMI) of less than 38.
• Potential subjects' THAs should be judged clinically successful with a HHS >90.
• Subjects must have demonstrated no evidence of post-operative hip subluxation or dislocation.
• Subjects must not walk with a detectable limp and must be able to actively abduct their operated hip against gravity without difficulty.
• Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without assistance.
• Patients from the physician's list who do not meet the study requirements will not be considered.
• Patients must be willing to sign the Informed Consent (IC)/HIPAA form to participate in the study.

• Patients must not have any kind of hip implant.
• Subjects must not have had any type of hip surgery or any pathological hip conditions, including osteoarthritis, or hip pain.
• Patients must be between the ages of 18 and 65.
• Potential subjects will have a body weight of less than 250 lbs.
• Participants must have BMI of less than 38.
• Pregnant or potentially pregnant females will be excluded from the study. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
• Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without aid of any kind or have had any kind of surgical procedure within the past 6 months that would affect his/her ability to perform the study activities.
• Patients must be willing to sign the IC and HIPAA forms to participate in the study.
• Patients must be between 160cm (5'3) and 193cm (6'4) tall

Exclusion Criteria

• Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
• Subjects without one of the two types of required hip implants.
• Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
• Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
• Subjects with pain, functional deficits, or generalized inflammatory.
• Subjects who walk with a detectable limp.
• Subjects who cannot actively abduct their operated hip against gravity without difficulty.
• Subjects who are unwilling to sign IC/HIPAA document.
• Subjects who have a HHS <90.

• Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study
• Subjects with any kind of hip implant.
• Subjects who have had any past hip surgery, have pathological hip conditions and/or hip pain.
• Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
• Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
• Subjects who are unwilling to sign IC/HIPAA document.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Richard Komistek

Fred M. Roddy Professor of Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Komistek, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

The University of Tennessee

Locations

Northside Hospital- Forsyth , GA 30041

Cumming, Georgia, United States

Abercrombie Radiology

Knoxville, Tennessee, United States

The University of Tennessee

Knoxville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIS-14002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2631FB

Identifier Type: -

Identifier Source: org_study_id