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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02335710

Enrollment

Registered

2015-01-12

Start date

2014-07-31

Completion date

2016-07-31

Last updated

2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

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.

Interventions

DEVICEJourney II BCS TKA

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Kinematics Translations During Ramp up Activity	3 months post-operative	AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity
Kinematics During Ramp up Activity	3 months post-operative	AR of the femur during Ramp Up activity
Kinematics During Squat to Stand (S2S) Activity	3 months post-operative	Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S
Kinematics Translations During Deep Knee Bend (DKB) Activity	3 months post-operative	Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB
Kinematics During Deep Knee Bend (DKB) Activity	3 months post-operative	Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Kinematics Translations During Squat to Stand (S2S) Activity	3 months post-operative	Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S
Kinematics Translations During Ramp Down Activity	3 months post-operative	AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity
Kinematics During Ramp Down Activity	3 months post-operative	AR of the femur during ramp down activity

Countries

United States

Participant flow

Participants by arm

Arm	Count
Smith & Nephew Journey II BCS TKA Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates Journey II BCS TKA	40
Normal Knee Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies	10
Total	50

Baseline characteristics

Characteristic	Smith & Nephew Journey II BCS TKA	Normal Knee	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	29 Participants	1 Participants	30 Participants
Age, Categorical Between 18 and 65 years	11 Participants	9 Participants	20 Participants
Age, Continuous	69.76 years STANDARD_DEVIATION 8.3	57.44 years STANDARD_DEVIATION 7.15	67.29 years STANDARD_DEVIATION 9.43
Sex: Female, Male Female	27 Participants	6 Participants	33 Participants
Sex: Female, Male Male	13 Participants	4 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 40	0 / 10
serious Total, serious adverse events	0 / 40	0 / 10