Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:40 - 85
Updated:4/21/2016
Start Date:July 2014
End Date:March 2016
Contact:Richard D Komistek, Ph D
Email:rkomiste@utk.edu
Phone:8659744159

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In Vivo Comparison of Knee Kinematics for Subjects Implanted With a Smith & Nephew Journey PS TKA and Subjects Having a Normal Knee

Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty
was analyzed by the Center for Musculoskeletal Research in a past research study, and it was
determined that subjects experienced more normal-like kinematic patterns. They also achieved
excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew
has made modifications to the Journey BCS TKA design, researchers will again evaluate the
kinematics of subjects implanted with the revised design to determine if subjects experience
normal-like kinematic patterns and if greater weight-bearing knee flexion is achieved. The
objective for this study is to analyze the in vivo kinematics for subjects implanted with a
2nd generation Journey BCS TKA and compare those patterns to subjects having a normal knee
and those having the 1st generation Journey PS TKA that were analyzed in the previous study


Inclusion Criteria for implanted subjects:

- Implanted with a Journey II BCS

- At least 3 months post-operative with no other surgical procedures within the past 6
months

- Body Mass Index < 40

- Body weight < 250 lbs

- Not pregnant

- Knee Society score of > 90

- Must be able to walk on level ground without aid of any kind

- Must be able to perform deep knee bend activity without aid of any kind

- Must be able to perform chair-rise activity without aid of any kind

- Must be willing to sign both Informed Consent and HIPAA forms

- Speak English

Exclusion Criteria for implanted subjects:

- Other surgical procedures performed within the past 6 months

- < 3 months post-operative

- Pregnant

- Severe cardiopulmonary or neurologic disease

- Body weight > 250 lbs

- BMI > 40

- KSS < 90

- Unable to perform 3 required activities unassisted

- Unwilling to sign both Informed Consent and HIPAA forms

- Prisoner

- Mental disease

- Unable to speak English

Inclusion Criteria for non-implanted subjects:

- healthy, well-functioning knee with no osteoarthritis or knee pathologies

- no other surgical procedures within the past 6 months that will prohibit them from
performing the three required activities

- Body Mass Index < 40

- Body weight < 250 lbs

- Not pregnant

- Knee Society score of > 90

- Must be able to walk on level ground without aid of any kind

- Must be able to perform deep knee bend activity without aid of any kind

- Must be able to perform chair-rise activity without aid of any kind

- Must be willing to sign both Informed Consent and HIPAA forms

- Speak English

Exclusion Criteria for non-implanted subjects:

- Other surgical procedures performed within the past 6 months that would prohibit them
from performing three required activities

- Any past knee pathologies, osteoarthritis or knee surgeries, including implants

- Pregnant

- Severe cardiopulmonary or neurologic disease

- Body weight > 250 lbs

- BMI > 40

- KSS < 90

- Unable to perform 3 required activities unassisted

- Unwilling to sign both Informed Consent and HIPAA forms

- Prisoner

- Mental disease

- Unable to speak English
We found this trial at
3
sites
Knoxville, Tennessee 37923
Principal Investigator: Harold E Cates, MD
Phone: 865-373-1811
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Knoxville, Tennessee 37923
Principal Investigator: Harold E Cates, MD
Phone: 865-373-1811
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mi
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Knoxville, TN
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Knoxville, Tennessee 37920
Phone: 865-974-2093
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Knoxville, TN
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