In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Conditions: Hip Injuries
Sponsor: The University of Tennessee, Knoxville

 
July 09, 2019 
  
IRB Protocol#: UTK IRB-15-02631-FB 
Title: In vivo determination of THA kinematics and sound for subjects for normal, diseased and 
implanted hips 
  
  
Richard David Komistek 
UTK - College of Engineering - Mech Aero &Biomed Engineering 
  
  
Dear Richard David Komistek: 
  
The UTK Institutional Review Board (IRB) received a Form 7 indicating the project referenced above has 
been completed.  The original date of approval date for the study is 12/17/2015.  The effective date of 
closure is 07/09/2019. The IRB determined that no further information is required from you for this 
protocol. 
  
As of the closure date, no further work is authorized by the IRB, including recruitment, consenting, data 
collection, or analysis of any related data.  If this study received funding, no further monies are to be 
committed as of the closure date.  For funded studies, a copy of this letter will be forwarded to the Office 
of Sponsored Programs. 
  
The IRB determined that no further information is required from you for this protocol. 
  
Sincerely, 
 
Colleen Gilrane, Ph.D. 
Chair 

In vivo determination of THA kinematics and sound for normal, 
diseased and implanted hips 
 
Richard D Komistek, PhD 
University of Tennessee 
1506 Middle Drive 
310 Perkins Hall 
Knoxville, TN 37996 
Phone: (865) 974-2093 
Fax: (865) 946-1787 
Email: rkomiste@utk.edu 
 
In vivo kinematics and acoustics will be assessed for 20 subjects for this study: 10 normal hips 
and 10 ten hips will be diseased, requiring a THA and then those same ten diseased hips will be 
reanalyzed at least six months post-operative after implantation of a THA manufactured by 
DePuy Synthes by Dr. Charles DeCook of Northside Hospital Forsyth [1200 Northside Forsyth 
Drive, Cumming, GA 30041]: this is the location from which all study participants will be 
recruited. Ten subjects will be implanted with a similar surgical technique and will be implanted 
with either a Summit/Pinnacle THA or Corail/Pinnacle THA. All THAs should be judged 
clinically successful (Harris Hip Scores HHS> 90 points), without pain, functional deficits, or 
generalized inflammatory. All subjects must have demonstrated no evidence of post-operative 
hip subluxation or dislocation.  The remaining ten subjects will have normal hips. None of the 
subjects can walk with a detectable limp and all subjects must be able to actively abduct their 
operated or healthy hip against gravity without difficulty.  
    
Deciding which patients receive which of the two kinds of implants is up to the discretion of Dr. 
DeCook, according to his professional opinion. The determination as to which type of implant 
patients receive is outside the scope of this particular study. Participation in the study is entirely 
voluntary, and the patient’s decision as to whether or not to participate will not impact the type 
or quality of care provided by the surgeon or his staff. 
 
We will use the following inclusion criteria to recruit participants for the diseased/implanted 
cohort of this study: 
1. Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or 
Corail/Pinnacle THA by Dr. Charles DeCook. 
2. For Phase 2, subjects 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. 
3. Subjects must be between 40-85 years of age. 
4. Potential subjects will have a body weight of less than 250 lbs. 
5. Participants must have Body Mass Index (BMI) of less than 38. 
6. Potential subjects’ THAs should be judged clinically successful with a HHS >90. 
7. Subjects must have demonstrated no evidence of post-operative hip subluxation or 
dislocation. 
8. Subjects must not walk with a detectable limp and must be able to actively abduct their 
operated hip against gravity without difficulty. 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
9. Participants must be able to walk on level ground, ascend and descend a ramp and rise 
from a chair without assistance. 
10. Subjects from the physician’s list who do not meet the study requirements will not be 
considered.  
11. Subjects must be willing to sign the Informed Consent (IC)/HIPAA form to participate in 
the study. 
 
Exclusion criteria: 
1. 
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. 
2. 
Subjects without one of the two types of required hip implants. 
3. 
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. 
4. 
Subjects who are unable to perform level walking, ascend and descend a ramp and 
rise from a chair without aid or support. 
5. 
Subjects with pain, functional deficits, or generalized inflammatory.   
6. 
Subjects who walk with a detectable limp. 
7. 
Subjects who cannot actively abduct their operated hip against gravity without 
difficulty. 
8. 
Subjects who are unwilling to sign IC/HIPAA document. 
9. 
Subjects who have a HHS <90. 
 
*In orthopaedics, the Harris Hip Score (HHS) evaluates clinical outcomes to determine the 
patient’s post-operative results. A patient who receives a HHS score > 90 is considered excellent.   
 
We will use the following inclusion criteria to recruit participants for the normal hip cohort of 
this study: 
1. 
Subjects must not have any kind of hip implant. 
2. 
Subjects must not have had any type of hip surgery or any pathological hip 
conditions, including osteoarthritis, or hip pain. 
3. 
Subjects must be between the ages of 18 and 65.  
4.  
Potential subjects will have a body weight of less than 250 lbs. 
5. 
Participants must have BMI of less than 38. 
6. 
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. 
7. 
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. 
8. 
Subjects must be willing to sign the IC and HIPAA forms to participate in the 
study. 
9. 
Subjects must be between 160cm (5’3) and 193cm (6’4) tall. 
 
Exclusion criteria: 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
1. 
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 
2. 
Subjects with any kind of hip implant. 
3. 
Subjects who have had any past hip surgery, have pathological hip conditions 
and/or hip pain. 
4. 
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. 
5. 
Subjects who are unable to perform level walking, ascend and descend a ramp and 
rise from a chair without aid or support. 
6. 
Subjects who are unwilling to sign IC/HIPAA document. 
 
Study locations 
Subject Recruitment (both diseased/implanted and normal groups):  
Practice of Dr. Charles DeCook: 
Northside Hospital- Forsyth 
1200 Northside Forsyth Dr. 
Cumming, GA 30041 
 
Computer Tomography (CT) scans: 
Northside Hospital- Forsyth 
1200 Northside Forsyth Dr. 
Cumming, GA 30041 
 
Pre-operative, diseased and normal hip fluoroscopic exams performed on all 20 subjects:  
Dougherty Engineering Building  
The University of Tennessee 
1512 Middle Dr. 
Knoxville, TN 37996 
 
Post-operative fluoroscopy data collection for implanted subjects performed:  
Abercrombie Radiology 
Weisgarber Medical Center 
1112 Weisgarber Rd. 
Knoxville, TN 37909 
 
Analysis will take place at the University of Tennessee’s Center for Musculoskeletal Research 
laboratories:  
Science and Engineering Research Facility  
1414 Circle Dr.  
Knoxville, TN 37996 
 
CMR administrative offices: 
Perkins Hall  
1506 Middle Dr.  

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
Knoxville, TN 37996 
 
Recruitment and Consenting of Diseased Hip/Implanted Subjects 
Dr. DeCook will recommend eligible patients for recruitment that require THA who will be 
implanted with either the DePuy Summit/Pinnacle THA or Corail/Pinnacle THA. Dr. DeCook’s 
staff will review those patients’ medical records to determine if they meet the remaining 
eligibility requirements for the study according to the study-specific criteria. Dr. DeCook may 
discuss participation with potentially eligible participants during regularly scheduled office visits 
or may recommend certain patients who are eligible to his staff who will then contact the patients 
to explain the study via telephone utilizing a script and inquire as to whether or not they are 
interested in participating; if a patient is agreeable to participate, s/he will schedule a visit to Dr. 
DeCook’s practice where s/he will be consented by Dr. DeCook’s staff. Dr. DeCook will not be 
present during the consenting process or during any of the procedures to be conducted to avoid 
possible patient coercion to participate. 
 
Recruitment and Consenting of Normal Hip Subjects 
For the ten normal hips, these participants will be recruited from the surgeon’s office by means 
of a displayed recruitment flyer. Potential subjects will be advised per the flyer to contact Dr. 
DeCook’s assistant to inform her of their willingness to participate and schedule a visit to Dr. 
DeCook’s practice to discuss any questions they may have about the study and collect the 
information from inclusion criteria listed above from the subjects to ensure eligibility 
requirements are met. After Dr. DeCook’s staff has determined eligibility requirements are met, 
s/he will consent the subject, using the IC/HIPAA as a guide, including the risks and benefits 
associated with participation and will answer any questions potential subjects may have about 
participation. Signing this form gives Dr. DeCook’s staff the ability to relate the information 
collected from the normal hip subjects during the consenting visit to UT researchers to aid in the 
interpretation of the results and correlate clinical outcomes versus kinematic results. After the 
subject is officially enrolled in the study (i.e., has signed IC/HIPAA form), Dr. DeCook will 
examine the subject’s hip to determine the normalcy of it and s/he will be scheduled for the CT 
scan.  
 
Procedures 
Computer Tomography 
Since the normal and diseased, pre-operative hip subjects will undergo a computer tomography 
(CT) scan of the hip so researchers can create the bone models necessary to analyze the hip data 
acquired after the fluoroscopy collection. These normal and pre-operative bone models will be 
compared to the computer-aided designed (CAD) bone models created from data acquired from 
DePuy’s implant-specific information (size, reference and lot numbers), all of which will be used 
in the analysis of the fluoroscopy and sound data obtained during data collection.  
 
The CT scans for the normal subjects and diseased/pre-operative THA patients will take place at 
Northside Hospital Forsyth [1200 Northside Forsyth Drive, Cumming, GA 30041] six inches 
distally on the femur and six inches proximally on the pelvis. The study will be submitted to 
Northside Hospital’s Institutional Review Board for review and approval. After CT scans have 
been conducted, they will be provided to UT researchers by mail/courier or secure electronic 
transfer to CMR researchers.  

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
 
Fluoroscopy Data Collection at the University of Tennessee  
Subjects with a normal hip will travel to Knoxville for the fluoroscopy/sound data collection one 
time, while subjects with a diseased and then implanted hip will travel to Knoxville for data 
collection twice, once pre-operatively and a second time at least 6 months post-operatively. 
  
In addition to fluoroscopy video, subjects will be videotaped from the torso down (to maintain 
patient anonymity) while performing the activities (live feed perspective). The speed level of 
each trial will be based on the comfort level of the subject. Activities will be performed without 
the aid of handrails; however, one of the researchers will be ready and in close proximity to 
assist each patient in case the participant requires help. This precaution will be practiced for all 
participants, regardless of physical wellbeing, age or prior results; no assumptions will be made 
as to any participant’s capabilities. 
 
Subjects will be video-recorded from the waist down while performing the activities while under 
fluoroscopy surveillance. The speed level of each trial will be based on the comfort level of the 
patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure 
servers and workstations at UT. In vivo hip kinematics will be assessed for all 10 normal 
subjects, the 10 diseased hip/pre-operative subjects who will be assessed again after they have 
been implanted with THA at least six months post-operatively.  
 
On the day of data collection, there will be at least three UT researchers present to conduct the 
fluoroscopic evaluations, as well as a State of Tennessee or ARRT certified Radiation 
Technician (RT) to run the x-ray component of the machine. These three UT researchers, 
graduate research assistants (GRAs), will be appointed by either Drs. Richard Komistek or 
William Hamel and will have significant experience with this particular tracking fluoroscope 
system (TFS).  
 
Fluoroscopy Activity 
Normal Gait (walking) 
1. With the fluoroscopic unit in the off position (no radiation), the subject will be asked to 
practice the activity.  
2. The subject will begin standing in a resting position and when ready will take a step 
leading with her/his implanted (or normal in case of normal subjects) hip in focus and 
proceed to walk at a comfortable pace for approximately 10 paces, or until instructed to 
stop. 
3. Once the subject and researchers are ready to begin after the practice, the subject will 
return to starting position. 
4. The radiation technician (RT) will start the fluoroscopic machine (x-ray on). 
5. The subject will perform the gait activity as the mobile fluoroscopy unit tracks the 
implanted hip. 
6. The RT will stop the fluoroscopic procedure after the patient successfully performs the 
maneuver twice or after two minutes of fluoroscopic “on-time” elapses.  
 
Participants will be asked to practice the activity to ensure they can comfortably complete them 
and experience no pain with the fluoroscopy machine off (no radiation). The practice portion 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
without radiation will not be video-recorded. During the fluoroscopy procedure, the implanted 
hip will be tracked by the mobile fluoroscopy machine and the hip joint is the only area in which 
radiation will be directed.  The subject will perform the activities until successful movements of 
each activity have been acquired, or a fluoroscopic “on-time” of two minutes is achieved. The 
participant will be allowed to rest as necessary and be instructed to stop the activities at the first 
sign of pain. 
 
The fluoroscopic footage for these activities will be stored on digital video files on a computer 
workstation, and participant information will be removed and replaced with identifiers by 
researchers selected by Dr. Komistek to lead the study, which will include graduate research 
assistants and other researchers. All researchers with access to identifiable subject data will sign 
statements of confidentiality. This de-identified data will then be uploaded onto a secure server.  
Each participant will be under fluoroscopic surveillance for less than or equal to 2 minutes and 
only the hip joint (from the fluoroscopy machine) will be recorded on the videotape.  Individual 
still frames will be collected from the fluoroscopic video and these frames will be evaluated for 
hip sliding or separation. These frames from subject fluoroscopy will be loaded into a database 
for analysis.  
 
Mobile Tracking Fluoroscopy System (TFS) 
The TFS is similar to a standard fluoroscope in that it emits x-rays in a stream that produces a 
motion picture x-ray of the object in question, in this case, the implanted joint.  The difference 
between the standard fluoroscope and the TFS is that the TFS is motorized with an automatic 
tracking system that monitors the surrounding environment and itself.  This allows the subject to 
move freely while the implanted joint is accurately tracked by the machine.  
 
The TFS is not currently FDA approved, and each study wherein the machine will be used must 
be approved by the State of Tennessee for use within the State of Tennessee. Approvals from 
both the State of Tennessee and the IRBs of UTK and Northside Hospital were acquired for the 
pre-operative stage of the study.  
 
Sound Data Acquisition 
Previously, the Center for Musculoskeletal Research has used in vivo sound sensors to detect 
sound within the hip and knee joints. These sensors have detected some remarkable sounds for 
different bearing surfaces that represent variable interactive conditions.  Patients with normal 
knees, degenerative osteoarthritic knees and well-functioning THAs have been analyzed under in 
vivo conditions using video fluoroscopy and vibration sensors while performing various normal 
day activities.  
 
For this study, the data capture set-up will consist of video cameras, accelerometers, signal 
conditioners, a data acquisition system, and a synchronization trigger.  Sound/vibration data 
collection will be performed simultaneously with the fluoroscopic exam to ensure the vibration 
data completely correlates with the 3D kinematics. 
 
Private Health Information/Medical Record Data 
The surgeon and his staff will provide subjects’ clinical information from their medical records – 
PHI – to Dr. Komistek and his researchers to aid in the interpretation of the results and correlate 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
clinical outcomes versus kinematic results, although only researchers present during data 
collection or those appointed by Dr. Komistek to lead the study will have access to PHI; they 
will sign confidentiality statements.  
 
The clinical/demographic information acquired from the medical records with participant 
authorization obtained as required by HIPAA will include: 
 the range-of-motion (pre-operative and 6 months post-operative),  
 activity level,  
 athletic activities able to perform,  
 DOB (or age at time of surgery), body weight, height, Body Mass Index (BMI) 
 date of surgery 
 pre-operative and post-operative HHS 
 previous medical assessments that are not a part of this particular research study, that 
may alter the kinematic results, such as previous hip x-rays, 
 post-operative time and any other conditions that may alter the kinematic results, such as 
back problems, ankle fusion, or contra-lateral hip problems.  
 
The surgeon’s office will also relate the implant component information:  
 Size of (including offsets): acetabular cup, acetabular liner, femoral stem, femoral 
head 
 Product/Reference # of: acetabular cup, acetabular liner, femoral stem, femoral 
head 
 Lot # of: acetabular cup, acetabular liner, femoral stem, femoral head 
 
The subject data – fluoroscopy frames, video footage, and sound – will be de-identified by the 
researcher(s) who attend data collection or appointed by Dr. Komistek and then stored on CMR’s 
secure server for use in future studies (if participant permission is obtained via IC); the 
individuals not indicated as Investigators with access to PHI will sign a pledges of 
confidentiality. Researchers would like to retain this de-identified data in our secure database so 
as to continue to add relevant, current data to our digital collection to help us work with 
manufacturers in the future to create better implants that last longer and will not require revision 
surgery. Participants will be asked if their de-identified data may remain a part of the CMR data 
collection for use in future studies in the IC. Likewise, should a patient choose to withdraw from 
the study, s/he will have the option as to whether or not data collected from them at the point of 
withdrawal may be used for data analysis or if their information should be provided to them and 
destroyed from CMR records; patients choosing to withdraw will be asked to complete a 
Revocation of Consent wherein they may indicate their preference regarding the data collected 
from them.  
 
Participant Confidentiality  
The investigators will ensure subject confidentiality is maintained throughout the study and after. 
Researchers not notated as Investigators of this study that have access to PHI will sign pledges of 
confidentiality. 
 
Hard Copy: 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
In compliance with HIPAA regulations, all participants will have their identities withheld from 
all public files. Individuals not indicated as investigators below will have access to participant 
information and they will sign pledges of confidentiality. The personnel in the following list will 
have access to private participant information: 
 
List of Persons Involved in Research: 
 Dr. Richard Komistek, PI, UT Professor, Biomedical Engineering 
 Dr. William Hamel, Co-PI, UT Professor, Mechanical Engineering 
 Dr. Charles DeCook, Co-PI, Northside Hospital, Orthopaedic Surgeon 
 Selected staff from Dr. DeCook’s office. 
 Radiation technician(s) will operate the fluoroscopy machine.  
 Rebecca Robertson, Research Coordinator III. 
 Researchers present during data collection at the University of Tennessee and/or the lead 
researchers appointed by Dr. Komistek.  
 * Undergraduate student researchers employed by CMR will be involved in 
analyzing the data after it has been collected, de-identified and transferred to 
CMR’s digital data collection. Since patient information will be removed and 
replaced with the assigned identifiers before the data is transferred to the 
database, it will not be possible for these undergraduate students to be able to 
identify patients. They will only have access to the de-identified data that has 
been uploaded onto the secure CMR digital collection. These student researchers 
will not have contact with patients. 
 Institutional Review Boards 
 The University of Tennessee 
 Northside Hospital  
 
BENEFITS 
The potential benefits from this study include, but are not limited to: 
 Subject stipend  
 Better understanding of the joints analyzed with the same technique in the past. 
 Future implant design improvements based on the kinematic findings. 
 New and advanced surgical techniques for THA based on the results.  
 There are no direct health benefits to participants of the study.  
 
Remuneration/Compensation for Travel Expenses  
Subjects were paid a stipend agreed upon by the sponsor and were also compensated for their 
travel to Knoxville. 
 
Clinical Observations: 
There are no clinical observations made during this data collection or from the images obtained 
through data collection. There will be no radiology report generated for this procedure conducted 
as a result of this study. Therefore, no RT will review such a report for the procedures, which 
would be the only way such a “significant problem” would be determined. No data will be 
returned to the surgeon’s office for evaluation or surgeon review, and therefore, the imaging 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
collected during this study will not potentially provide benefit to specific patients by influencing 
the physician’s treatment plan. 
 
METHODS TO OBTAIN INFORMED CONSENT FROM PARTICIPANTS 
Informed consent will be obtained prior to any procedures being conducted. Subjects from both 
cohorts who are agreeable to participate will schedule a visit to Dr. DeCook’s practice where 
s/he will be consented by Dr. DeCook’s staff. Dr. DeCook was not present during the consenting 
process to avoid possible patient coercion to participate. Consenting staff will use the IC/HIPAA 
as a guide, including the risks and benefits associated with participation and will answer any 
questions potential subjects may have about participation. 
 
Phase 2: Post-Operative Fluoroscopy data collection 
For Phase 2 of the study, only seven of the ten hips that were diseased and required a THA that 
participated in Phase 1 of the study in Knoxville were reachable to participate in post-operative 
fluoroscopy at Abercrombie.  Radiology in Knoxville, TN Weisgarber Medical Center, 1112 
Weisgarber Rd., Knoxville, TN 37909.  
 
The following inclusion criteria were used to ensure hip subjects that participated in Phase 1 
meet eligibility for continuing participation in Phase 2: 
1. Subjects required a THA and were implanted with either Summit/Pinnacle THA or 
Corail/Pinnacle THA by Dr. Charles DeCook. 
2. All subjects are well past the required six months post-operative time. 
3. Subjects must be between 40-85 years of age. 
4. Potential subjects will have a body weight equal to or less than 300 lbs. 
5. Participants must have Body Mass Index (BMI) of less than 40. 
6. Potential subjects’ THAs should be judged clinically successful with a HHS >90. 
7. Participants must be able to walk on level ground without assistance. 
8. Subjects from the physician’s list who do not meet the study requirements will not be 
considered.  
9. Subjects must be willing to sign the Informed Consent (IC)/HIPAA form to participate in 
the study. 
 
To ensure that all subjects who participated in Phase 1 of the study still met all study eligibility 
requirements prior to undergoing the post-operative fluoroscopy procedure, a subject specific 
form was completed for each of the subjects prior to contact for scheduling of post-operative 
fluoroscopy visit. Dr. DeCook’s office staff will be responsible for reviewing the medical files of 
the subjects that participated in Phase 1 and using the checklist to ensure all subjects meet study 
criteria. If subjects meet the criteria, they will then be contacted by Dr. DeCook’s office to 
inform the subjects that the second phase of the study is underway and to schedule their 
appointments to Abercrombie Radiology in Knoxville.  
 
 
The same reimbursement of travel expenses applied to Phase 2 as was in place for Phase 1. To 
facilitate implanted subject post-operative participation and compensate for the delay between 
data collections, the stipend for the implanted group was increased. 
Due to protocol revisions (only performing gait activity), change in post-operative fluoroscopy 

 
 
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DePuy THA fluoroscopy protocol and statistical analysis 
data collection location (Abercrombie Radiology instead of UT campus), and increase in stipend, 
each subject will be consented again by UT researchers so subjects are aware and understand the 
changes to the study. After signing the revised IC form, s/he will be fitted with non-invasive, 
surface-based sound/vibration sensors placed at the closest distance to the hip joint interface, 
allowing for the capturing of sound emissions during the gait activity. The sensor will be 
securely attached using a spica dressing, a tight-fitting, sleeve-like article of clothing, designed 
for the purpose of the study, and adjusted to subject size using integrated Velcro strips. The 
sensors will be connected to a data acquisition system that will also be connected to the subject 
by thin, ultra-lightweight cables while s/he performs the level walking (gait) activity.  
 
In addition to fluoroscopy video, subjects will be videotaped from the torso down (to maintain 
subject anonymity) while performing the activity (live feed perspective) under fluoroscopy 
surveillance. The speed level of each trial will be based on the comfort level of the subject. The 
activity will be performed without the aid of handrails; however, one of the researchers will be 
ready and in close proximity to assist each subject in case the participant requires help. This 
precaution will be practiced for all participants, regardless of physical wellbeing, age or prior 
results; no assumptions will be made as to any participant’s capabilities. 
 
In vivo hip kinematics will be assessed for all 10 normal subjects, 10 diseased hip/pre-operative 
subjects and the same 10 subjects will be assessed again after they complete the post-operative  
 
Statistical Analysis 
Basic descriptive statistics (mean and standard deviation) were analyzed for femoral head center 
displacement from the acetabulum center for both implanted (post-operative) and non-implanted 
(normal, pre-operative) cases. This was evaluated for one complete gait cycle for each subject.