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CompletedNCT02335710Updated Oct 21, 2019Results posted

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

An observational study in Knee Injuries, sponsored by The University of Tennessee, Knoxville. Completed at 3 sites in United States. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by The University of Tennessee, Knoxville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Injuries

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03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 79 observational studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: Journey II BCS TKA

  • Normal knee

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

Interventions

  • DeviceJourney II BCS TKA
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months post-operative

  2. Kinematics During Deep Knee Bend (DKB) Activity

    Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB

    Time frame: 3 months post-operative

  3. 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

    Time frame: 3 months post-operative

  4. 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

    Time frame: 3 months post-operative

  5. Kinematics Translations During Ramp up Activity

    AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity

    Time frame: 3 months post-operative

  6. Kinematics During Ramp up Activity

    AR of the femur during Ramp Up activity

    Time frame: 3 months post-operative

  7. Kinematics Translations During Ramp Down Activity

    AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity

    Time frame: 3 months post-operative

  8. Kinematics During Ramp Down Activity

    AR of the femur during ramp down activity

    Time frame: 3 months post-operative

07

Results

Posted Aug 26, 2016

Participant flow

Participant flow — Overall Study
MilestoneSmith & Nephew Journey II BCS TKANormal Knee
Started4010
Completed4010
Not completed00

Outcome measures

PrimaryKinematics 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

Time frame:
3 months post-operative
Reported as:
Mean · mm
Kinematics Translations During Deep Knee Bend (DKB) Activity
mmSmith & Nephew Journey II BCS TKANormal Knee
AP trans lateral femoral condyles 0-90 degrees-10.11 ± 4.80-13.15 ± 4.78
AP trans medial femoral condyles 0-90 degrees-5.15 ± 2.51-4.93 ± 1.78
PrimaryKinematics During Deep Knee Bend (DKB) Activity

Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Kinematics During Deep Knee Bend (DKB) Activity
degreesSmith & Nephew Journey II BCS TKANormal Knee
Max weight-bearing flexion deep knee bend95.6 ± 20.5143.6 ± 10.5
AR of the femur 0-90 degrees6.23 ± 4.4417.88 ± 5.57
PrimaryKinematics 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

Time frame:
3 months post-operative
Reported as:
Mean · mm
Kinematics Translations During Squat to Stand (S2S) Activity
mmSmith & Nephew Journey II BCS TKANormal Knee
AP trans of lateral femoral condyle 90-0 degrees11.82 ± 4.6811.30 ± 4.66
AP trans of medial femoral condyle 90-0 degrees5.49 ± 2.254.37 ± 2.12
PrimaryKinematics During Squat to Stand (S2S) Activity

Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Kinematics During Squat to Stand (S2S) Activity
degreesSmith & Nephew Journey II BCS TKANormal Knee
Kinematics During Squat to Stand (S2S) Activity-7.78 ± 4.92-15.31 ± 6.21
PrimaryKinematics Translations During Ramp up Activity

AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity

Time frame:
3 months post-operative
Reported as:
Mean · mm
Kinematics Translations During Ramp up Activity
mmSmith & Nephew Journey II BCS TKANormal Knee
Medial Anterior Posterior Translation 0% to 33%0.81 ± 3.05-1.51 ± 1.62
Medial Anterior Posterior Translation 33% to 66%1.21 ± 2.691.20 ± 1.15
Medial Anterior Posterior Translation 66% to 100%-3.16 ± 3.830.63 ± 1.44
Lateral Anterior Posterior Translation 0-33%0.40 ± 1.88-2.72 ± 3.18
Lateral Anterior Posterior Translation 33%-66%1.88 ± 3.503.43 ± 2.20
Lateral Anterior Posterior Translation 66%-100%-4.39 ± 5.63-2.24 ± 2.01
PrimaryKinematics During Ramp up Activity

AR of the femur during Ramp Up activity

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Kinematics During Ramp up Activity
degreesSmith & Nephew Journey II BCS TKANormal Knee
AR 0% to 33%0.50 ± 2.972.25 ± 4.15
AR 33% to 66%-0.82 ± 2.50-3.64 ± 3.13
AR 66% to 100%1.51 ± 3.673.76 ± 3.03
PrimaryKinematics Translations During Ramp Down Activity

AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity

Time frame:
3 months post-operative
Reported as:
Mean · mm
Kinematics Translations During Ramp Down Activity
mmSmith & Nephew Journey II BCS TKANormal Knee
Medial Anterior Posterior Translation 0% to 33%-0.56 ± 2.93-1.20 ± 1.39
Medial Anterior Posterior Translation 33% to 66%-1.34 ± 1.940.08 ± 1.21
Medial Anterior Posterior Translation 66% to 100%-0.35 ± 3.330.20 ± 2.25
Lateral Anterior Posterior Translation 0-33%-1.45 ± 4.52-2.59 ± 3.56
Lateral Anterior Posterior Translation 33%-66%-2.57 ± 3.15-1.85 ± 2.38
Lateral Anterior Posterior Translation 66%-100%-0.24 ± 4.901.36 ± 2.46
PrimaryKinematics During Ramp Down Activity

AR of the femur during ramp down activity

Time frame:
3 months post-operative
Reported as:
Mean · degrees
Kinematics During Ramp Down Activity
degreesSmith & Nephew Journey II BCS TKANormal Knee
AR 0% to 33%1.10 ± 3.183.30 ± 5.15
AR 33% to 66%1.54 ± 3.393.04 ± 3.35
AR 66% to 100%-0.15 ± 3.30-1.81 ± 3.01

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Smith & Nephew Journey II BCS TKA—0/40 (0%)0/40 (0%)
Normal Knee—0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Smith & Nephew Journey II BCS TKANormal KneeTotal
<=18 years000
Between 18 and 65 years11920
>=65 years29130
Age, Continuous
Age, Continuous(years)Smith & Nephew Journey II BCS TKANormal KneeTotal
Mean69.76 ± 8.3057.44 ± 7.1567.29 ± 9.43
Sex: Female, Male
Sex: Female, Male(Participants)Smith & Nephew Journey II BCS TKANormal KneeTotal
Female27633
Male13417
08

Study locations

3 sites
  • Tennessee Orthopaedic Clinic
    Knoxville, Tennessee 37923, United States
  • Tennessee Orthopaedic Foundation for Education and Research
    Knoxville, Tennessee 37923, United States
  • The University of Tennessee
    Knoxville, Tennessee 37996, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02335710
Lead sponsor
The University of Tennessee, Knoxville
Collaborators
Smith & Nephew, Inc.
Responsible party
Richard Komistek (Principal Investigator, The University of Tennessee, Knoxville) — Principal investigator
First posted
Jan 12, 2015
Start date
Jul 2014
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Aug 26, 2016
Last update
Oct 21, 2019

Study contacts

Richard D Komistek, Ph D
principal investigator · Employee

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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