Clinical trial NCT02335710: Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions
Official title: In Vivo Comparison of Knee Kinematics for Subjects Implanted With a Smith & Nephew Journey Posterior Stabilizing (PS) Total Knee Arthroplasty (TKA) and Subjects Having a Normal Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2015-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a Smith \& Nephew Journey II bi-cruciate stabilizing (BCS) implanted by Dr. Harold E. Cates or subjects with a healthy knee

Brief summary: 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 bi-cruciate stabilizing (BCS) total knee arthroplasty (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 posterior stabilizing (PS) TKA that were analyzed in the previous study.


Eligibility criteria: 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 (BMI) \< 40
* Body weight \< 250 lbs
* Not pregnant
* Knee Society score (KSS) 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

Primary outcomes:
measure: Kinematics Translations During Deep Knee Bend (DKB) Activity
timeFrame: 3 months post-operative
measure: Kinematics During Deep Knee Bend (DKB) Activity
timeFrame: 3 months post-operative
measure: Kinematics Translations During Squat to Stand (S2S) Activity
timeFrame: 3 months post-operative
measure: Kinematics During Squat to Stand (S2S) Activity
timeFrame: 3 months post-operative
measure: Kinematics Translations During Ramp up Activity
timeFrame: 3 months post-operative
measure: Kinematics During Ramp up Activity
timeFrame: 3 months post-operative
measure: Kinematics Translations During Ramp Down Activity
timeFrame: 3 months post-operative
measure: Kinematics During Ramp Down Activity
timeFrame: 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Foundation for Education and Research
state: Tennessee
city: Knoxville
country: United States
facility: The University of Tennessee
state: Tennessee
Study officials:
affiliation: Employee
name: Richard D Komistek, Ph D
role: PRINCIPAL_INVESTIGATOR
References: