Knee OsteoarthritisNCT04612036

In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by The University of Tennessee, Knoxville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
What is being tested?: Journey II Bi-Cruciate Stabilized TKA, Journey II Cruciate Retaining TKA and Journey II Bi-Cruciate Retaining TKA
Type of treatment: Medical device
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 22 Oct 2020to 16 May 2022
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
No healthy volunteers
Adult, Older adult

Study population: Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs

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, either the BCS or XR, 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.

United States1 site

The University of Tennessee
Knoxville, Tennessee, 37996

Other trials in United States

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

Read the detailed description

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. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.

Conditions: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
Being tested: Journey II Bi-Cruciate Stabilized TKA, Journey II Cruciate Retaining TKA, Journey II Bi-Cruciate Retaining TKA
Keywords: Total Knee Arthroplasty
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Journey II Bi-Cruciate Stabilized TKADevice
Total Knee Arthroplasty System
Journey II Cruciate Retaining TKADevice
Total Knee Arthroplasty System
Journey II Bi-Cruciate Retaining TKADevice
Total Knee Arthroplasty System

Study groups in NCT04612036
Study group	Role	What they receive
Journey II Bi-Cruciate Stabilized		Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Receives: Device: Journey II Bi-Cruciate Stabilized TKA
Journey II Cruciate Retaining		Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Receives: Device: Journey II Cruciate Retaining TKA
Journey II Bi-Cruciate Retaining		Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Receives: Device: Journey II Bi-Cruciate Retaining TKA

What is being measured

The primary outcome is the main question the study is designed to answer.

Medial AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Measured: At least 6 months postoperative
Lateral AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Measured: At least 6 months postoperative
Maximum Flexion, in Degrees
Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.
Measured: At least 6 months postoperative
Axial Rotation, in Degrees
Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.
Measured: At least 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 202016 May 2022

First posted2 Nov 2020
Study start22 Oct 2020
Primary completion16 May 2022
Study completion16 May 2022

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 OsteoarthritisStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04612036
Sponsor's protocol ID: WIRB20203268
Status last verified: Feb 2023
First submitted: 27 Oct 2020
Last updated: 29 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. 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: NCT04612036
Acronym / sponsor ID: WIRB20203268
Conditions: Knee Osteoarthritis, Total Knee Arthroplasty, Knee
Keywords: Total Knee Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Study start: 22 Oct 2020 (actual)
Primary completion: 16 May 2022 (actual)
Study completion: 16 May 2022 (actual)
First posted: 2 Nov 2020 (actual)
Results: Posted 29 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Journey II Bi-Cruciate Stabilized	–	Device: Journey II Bi-Cruciate Stabilized TKASubjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected
Journey II Cruciate Retaining	–	Device: Journey II Cruciate Retaining TKASubjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Journey II Bi-Cruciate Retaining	–	Device: Journey II Bi-Cruciate Retaining TKASubjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs

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
Journey II Bi-Cruciate Stabilized TKATotal Knee Arthroplasty System	Device	Journey II Bi-Cruciate Stabilized
Journey II Cruciate Retaining TKATotal Knee Arthroplasty System	Device	Journey II Cruciate Retaining
Journey II Bi-Cruciate Retaining TKATotal Knee Arthroplasty System	Device	Journey II Bi-Cruciate Retaining

Primary outcome

Medial AP Translations, in mm
Time frame: At least 6 months postoperative
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Lateral AP Translations, in mm
Time frame: At least 6 months postoperative
Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Maximum Flexion, in Degrees
Time frame: At least 6 months postoperative
Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.
Axial Rotation, in Degrees
Time frame: At least 6 months postoperative
Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.

Results and safety

Results posted to the registry on 29 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Journey II Bi-Cruciate Stabilized	25	25
Journey II Cruciate Retaining	25	25
Journey II Bi-Cruciate Retaining	10	10

Primary outcome: Medial AP Translations, in mm

Time frame: At least 6 months postoperative. Mean (Standard Deviation). Unit: millimeters

Measure	Journey II Bi-Cruciate Stabilized n = 25	Journey II Cruciate Retaining n = 25	Journey II Bi-Cruciate Retaining n = 10
Value	-6.9 (2.8)	-0.2 (4.3)	-4.4 (3.8)

Primary outcome: Lateral AP Translations, in mm

Time frame: At least 6 months postoperative. Mean (Standard Deviation). Unit: millimeters

Measure	Journey II Bi-Cruciate Stabilized n = 25	Journey II Cruciate Retaining n = 25	Journey II Bi-Cruciate Retaining n = 10
Value	-12.5 (5.0)	-4.7 (6.2)	-9.4 (6.1)

Primary outcome: Maximum Flexion, in Degrees

Time frame: At least 6 months postoperative. Mean (Standard Deviation). Unit: degrees

Measure	Journey II Bi-Cruciate Stabilized n = 25	Journey II Cruciate Retaining n = 25	Journey II Bi-Cruciate Retaining n = 10
Value	108 (13)	121 (6)	105 (13)

Primary outcome: Axial Rotation, in Degrees

Time frame: At least 6 months postoperative. Mean (Standard Deviation). Unit: degrees

Measure	Journey II Bi-Cruciate Stabilized n = 25	Journey II Cruciate Retaining n = 25	Journey II Bi-Cruciate Retaining n = 10
Value	7.1 (4.2)	5.6 (5.7)	6.0 (7.0)

Adverse events

Time frame: adverse events would be noted on day of data collection. therefore the adverse events would be noted immediately, i.e. 1 day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Journey II Bi-Cruciate Stabilized	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Journey II Cruciate Retaining	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Journey II Bi-Cruciate Retaining	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Related trials for Knee Osteoarthritis

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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.

Michael LaCour, PhD principal investigator

The University of Tennessee

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 Knee Osteoarthritis and 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 29 Nov 2023. 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 29 Nov 2023). 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?

Medial AP Translations, in mm (time frame: At least 6 months postoperative). 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?

On the ClinicalTrials.gov record for NCT04612036.

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 29 Nov 2023.