Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements Using Mobile Fluoroscopy



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:40 - 85
Updated:6/15/2017
Start Date:January 2017
End Date:November 2017
Contact:Richard Komistek
Email:rkomiste@utk.edu
Phone:8659744159

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The purpose of the study is to acquire kinematic in vivo fluoroscopy data using the
University of Tennessee's tracking fluoroscopy system (TFS) from subjects who were implanted
with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee
arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously
collected data for the Smith & Nephew BCS TKA and compared these kinematics data to those of
normal knees.

The objective for this study is to analyze the in vivo kinematics for subjects implanted
with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a
normal knee from our previous study and to those patterns from subjects having a Smith &
Nephew Journey II BCS TKA.

Inclusion Criteria:

- Must have must either a Smith & Nephew Journey II PCR or BCR TKA

- Must be at least three months post-operative

- Must have a Knee Society score of >90 with no ligamentous laxity or pain

- Weigh 250 pounds or less

- Should have good-to-excellent post-operative flexion

- Must be able to perform activities (without aid of any kind) and without pain,
walking up and down a ramp, performing a deep knee bend and rising from that kneeling
position after the deep knee bend

- Must not have had other surgical procedures conducted within the past six months that
will prohibit them from performing the study activities

- Must have body mass index (BMI) of less than 38

- Must be between 40-85 years of age

- Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms to
participate in the study

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 the required types of knee implants

- Subjects who are unable to walk up and down a ramp, perform a deep knee bend or
rising from that kneeling position without aid or support and without pain

- Subjects who have had other surgical procedures conducted within the past six months
that will prohibit them from performing the study activities
We found this trial at
3
sites
Knoxville, Tennessee 37920
Principal Investigator: Richard Komistek
Phone: 865-974-4159
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1534 White Avenue
Knoxville, Tennessee 37923
Principal Investigator: Harold Cates
Phone: 865-373-1811
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Knoxville, Tennessee 37923
Principal Investigator: Harold Cates
Phone: 865-690-4861
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