Total Knee ArthroplastyNCT05107414
Journey 2 Multi Center Kinematic Study
An observational study of Total Knee Arthroplasty, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 31 Dec 2024
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: All participants will be selected by their respective surgeons. Participants will be screened by eligible surgeon staff and will have the required implant for each site.
Who may be able to join
- Patients in the age range of 18 years to 85 years (both inclusive)
- Patients who have a BMI less than 35
- Patients who do not have previous surgery on the implanted knee that might restrict their movement
- Patient who are at least 6 months post-operative
- Patients who do not experience any pain or other post-operative complications
- Patients who have a stable TKA and can perform a deep knee bend activity
- Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
- Subjects will have a Journey II knee system
Who cannot join
- Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
- Patients who have currently enrolled in a fluoroscopic study within the past year.
- Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
- Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
- Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
- Subjects who are unable to perform a deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- Subjects without the required type of knee implant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyDevice
Also called Smith & Nephew Journey II TKA
Participants have previously undergone a total knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Journey II Bi-Cruciate Stabilized | Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA Receives: Device: Total Knee Arthroplasty | |
| Journey II Cruciate Retaining | Participants who have been implanted with a Smith \& Nephew Journey II CR TKA Receives: Device: Total Knee Arthroplasty | |
| Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA Receives: Device: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femorotibial Medial Condylar Rollback
The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].
Measured: Baseline, at time of observation
Femorotibial Lateral Condylar Rollback
The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].
Measured: Baseline, at time of observation
Femorotibial Axial Rotation
The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].
Measured: Baseline, at time of observation
Femorotibial Weight Bearing Flexion
The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].
Measured: Baseline, at time of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start15 May 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Total Knee ArthroplastyStudies 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107414
- Sponsor's protocol ID
- 20203268
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2021
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
- ClinicalTrials.gov ID
- NCT05107414
- Acronym / sponsor ID
- 20203268
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Journey II Bi-Cruciate Stabilized | – | Device: Total Knee ArthroplastyParticipants who have been implanted with a Smith \& Nephew Journey II BCS TKA |
| Journey II Cruciate Retaining | – | Device: Total Knee ArthroplastyParticipants who have been implanted with a Smith \& Nephew Journey II CR TKA |
| Journey II Bi-Cruciate Retaining | – | Device: Total Knee ArthroplastyParticipants who have been implanted with a Smith \& Nephew Journey II BCR TKA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All participants will be selected by their respective surgeons. Participants will be screened by eligible surgeon staff and will have the required implant for each site.
Key inclusion criteria (8 listed)
- Patients in the age range of 18 years to 85 years (both inclusive)
- Patients who have a BMI less than 35
- Patients who do not have previous surgery on the implanted knee that might restrict their movement
- Patient who are at least 6 months post-operative
- Patients who do not experience any pain or other post-operative complications
Key exclusion criteria (8 listed)
- Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
- Patients who have currently enrolled in a fluoroscopic study within the past year.
- Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
- Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
- Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: Smith & Nephew Journey II TKAParticipants have previously undergone a total knee replacement surgery. | Device | Journey II Bi-Cruciate Retaining, Journey II Bi-Cruciate Stabilized, Journey II Cruciate Retaining |
Primary outcome
Femorotibial Medial Condylar Rollback
Time frame: Baseline, at time of observation
The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].
Femorotibial Lateral Condylar Rollback
Time frame: Baseline, at time of observation
The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm].
Femorotibial Axial Rotation
Time frame: Baseline, at time of observation
The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].
Femorotibial Weight Bearing Flexion
Time frame: Baseline, at time of observation
The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg].
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by The University of Tennessee, Knoxville at 1 site 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 8 inclusion and 8 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 23 Jun 2026). 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?
Femorotibial Medial Condylar Rollback (time frame: Baseline, at time of observation). The study lists 4 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 23 Jun 2026.