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



Status:Active, not recruiting
Healthy:No
Age Range:40 - 85
Updated:1/13/2017
Start Date:April 2016
End Date:December 2017

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In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

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 six months post-operative after implantation of a THA.


Inclusion Criteria for diseased/implanted subjects:

- 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.

Exclusion Criteria for diseased/implanted subjects:

- 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.

Inclusion Criteria for normal subjects:

- 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 for normal subjects:

- 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.
We found this trial at
2
sites
Knoxville, Tennessee 37920
Principal Investigator: Richard Komistek, Ph. D.
Phone: 865-974-2093
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Cumming, Georgia 30041
Principal Investigator: Charles DeCook, MD
Phone: 404-236-8351
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Cumming, GA
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