N/A N=50

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

Knee Injuries

Bottom Line

View on ClinicalTrials.gov: NCT02335710 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Kinematics Translations During Deep Knee Bend (DKB) Activity — -10.11; -13.15; -5.15; -4.93 mm

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Journey II BCS TKA (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: The University of Tennessee, Knoxville
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Kinematics Translations During Deep Knee Bend (DKB) Activity	-10.11; -13.15; -5.15; -4.93	—
PRIMARY Kinematics During Deep Knee Bend (DKB) Activity	95.6; 143.6; 6.23; 17.88	—
PRIMARY Kinematics Translations During Squat to Stand (S2S) Activity	11.82; 11.30; 5.49; 4.37	—
PRIMARY Kinematics During Squat to Stand (S2S) Activity	-7.78; -15.31	—
PRIMARY Kinematics Translations During Ramp up Activity	0.81; -1.51; 1.21; 1.20; -3.16; 0.63	—
PRIMARY Kinematics During Ramp up Activity	0.50; 2.25; -0.82; -3.64; 1.51; 3.76	—
PRIMARY Kinematics Translations During Ramp Down Activity	-0.56; -1.20; -1.34; 0.08; -0.35; 0.20	—
PRIMARY Kinematics During Ramp Down Activity	1.10; 3.30; 1.54; 3.04; -0.15; -1.81	—

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) 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
250 lbs
BMI > 40
KSS 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02335710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.