Clinical trial NCT02682602: THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Official title: In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Injuries
Keywords: total hip arthroplasty
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2016-02-15
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Magnitude of Hip Separation During Primary Heel Strike
timeFrame: Approximately 2 years postoperatively.
measure: Magnitude of Hip Separation During Contra-lateral Toe Off
timeFrame: Approximately 2 years postoperatively.
measure: Magnitude of Hip Separation During Contra-lateral Heel Strike
timeFrame: Approximately 2 years postoperatively.
measure: Magnitude of Hip Separation During Primary Toe Off
timeFrame: Approximately 2 years postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Cumming
country: United States
facility: Northside Hospital- Forsyth , GA 30041
state: Georgia
city: Knoxville
country: United States
facility: Abercrombie Radiology
state: Tennessee
city: Knoxville
country: United States
facility: The University of Tennessee
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Richard Komistek, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: