Knee InjuriesNCT02335710
Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions
An observational study of Knee Injuries, run by The University of Tennessee, Knoxville at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Journey II BCS TKA
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to Jul 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Tennessee Orthopaedic Clinic
Knoxville, Tennessee, 37923
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, 37923
The University of Tennessee
Knoxville, Tennessee, 37996
About this study
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
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.
- Conditions
- Knee Injuries
- Being tested
- Journey II BCS TKA
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey II BCS TKADevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Journey II BCS TKA | |
| Normal knee | Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post-operative
Kinematics During Deep Knee Bend (DKB) Activity
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Measured: 3 months post-operative
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
Measured: 3 months post-operative
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
Measured: 3 months post-operative
Kinematics Translations During Ramp up Activity
AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity
Measured: 3 months post-operative
Kinematics During Ramp up Activity
AR of the femur during Ramp Up activity
Measured: 3 months post-operative
Kinematics Translations During Ramp Down Activity
AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity
Measured: 3 months post-operative
Kinematics During Ramp Down Activity
AR of the femur during ramp down activity
Measured: 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Richard D Komistek, Ph D, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335710
- Sponsor's protocol ID
- R011373506
- Status last verified
- Oct 2019
- First submitted
- 7 Jan 2015
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02335710
- Acronym / sponsor ID
- R011373506
- Conditions
- Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smith & Nephew Journey II BCS TKA | – | Device: Journey II BCS TKASubjects must be implanted with a Smith \& Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates |
| Normal knee | – | –Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (24 listed)
- Other surgical procedures performed within the past 6 months
- < 3 months post-operative
- Pregnant
- Severe cardiopulmonary or neurologic disease
- Body weight > 250 lbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Journey II BCS TKA | Device | Smith & Nephew Journey II BCS TKA |
Primary outcome
Kinematics Translations During Deep Knee Bend (DKB) Activity
Time frame: 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
Time frame: 3 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Kinematics Translations During Squat to Stand (S2S) Activity
Time frame: 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 During Squat to Stand (S2S) Activity
Time frame: 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 Ramp up Activity
Time frame: 3 months post-operative
AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity
Kinematics During Ramp up Activity
Time frame: 3 months post-operative
AR of the femur during Ramp Up activity
Kinematics Translations During Ramp Down Activity
Time frame: 3 months post-operative
AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity
Kinematics During Ramp Down Activity
Time frame: 3 months post-operative
AR of the femur during ramp down activity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Komistek, Ph D principal investigator
Employee
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by The University of Tennessee, Knoxville at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics Translations During Deep Knee Bend (DKB) Activity (time frame: 3 months post-operative). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.