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 |
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
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
Click here to add this to my saved trials
Knoxville, Tennessee 37923
Principal Investigator: Harold E Cates, MD
Phone: 865-373-1811
Click here to add this to my saved trials
Click here to add this to my saved trials