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

The University of Tennessee, Knoxville

Status: Completed

Conditions: Knee Injuries

Treatments: Device: Journey II BCS TKA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02335710

R011373506

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

50 participants in 2 patient groups

Smith & Nephew Journey II BCS TKA

Description:

Subjects must be implanted with a Smith \& Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates

Treatment:

Device: Journey II BCS TKA

Normal knee

Description:

Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies