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

Knee Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335710
• Other study ID #: R011373506
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2019
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• Journey II BCS TKA

Locations

Country	Name	City	State
United States	Tennessee Orthopaedic Clinic	Knoxville	Tennessee
United States	Tennessee Orthopaedic Foundation for Education and Research	Knoxville	Tennessee
United States	The University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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