Journey II XR Total Knee SystemJIIXRNCT03798847
Safety and Performance of Journey II XR Total Knee System
An observational study of Journey II XR Total Knee System, run by Smith & Nephew, Inc. at 12 sites in United States.
Trial summary
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Journey II XR Total Knee System
- What is being tested?
- Journey II XR TKA
- Type of treatment
- Medical device
- How many people
- 683 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Nov 2018to 10 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
Who may be able to join
- Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
- The TKA occurred at least 12 weeks prior to enrollment.
Who cannot join
- None
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Anderson Orthopaedic Clinic
Alexandria, Virginia, 22306
Rush Copley Orthopaedics
Aurora, Illinois, 60504
Scott Orthopedic Center
Huntington, West Virginia, 25702
Aurora Medical Center
Kenosha, Wisconsin, 53142
Hospital for Joint Diseases Orthopaedics Institute
New York, New York, 10003
Regenerative Orthopedic Center (ROC)
Oregon City, Oregon, 97045
Orthopedic Institute of the West
Phoenix, Arizona, 85054
Jerry Orthopaedic Institute
Port Huron, Michigan, 48060
Oregon Health & Science University
Portland, Oregon, 97239
Reno Orthopedic Clinic
Reno, Nevada, 89503
San Antonio Orthopaedic Specialists
San Antonio, Texas, 78258
Orthopaedic Center of New Jersey
Somerset, New Jersey, 08873
About this study
Official title: Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
- Conditions
- Journey II XR Total Knee System
- Being tested
- Journey II XR TKA
- Keywords
- Journey II XR Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey II XR TKADevice
Journey II XR Total Knee System
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision of one or more study device components
Measure of the number of revision cases
Measured: 12 weeks follow up
Secondary outcomes (10)
Adverse Events
All collected and reported AEs
Measured: 12 weeks follow up
Health care utilization: Hospitalization
Length of hospital stay for primary (index) surgery
Measured: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
Measured: Implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
number of sessions and duration of rehabilitation in weeks
Measured: Implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Number and type of outpatient visits
Measured: Implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
Number of re-operations and revisions
Measured: Implantation through study completion, approximately 3 years
Quality of Life: EQ-5D-3L
EuroQol Five Dimensions Questionnaire
Measured: Implantation through study completion, approximately 3 years
Quality of Life: KSS
2011 Knee Society Score
Measured: Implantation through study completion, approximately 3 years
Return to Work
Changes in employment status will be recorded with the date on which the change occurred and the change status.
Measured: Implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Number of technical difficulties encountered with the device
Measured: Implantation through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Nov 2018
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Journey II XR Total Knee SystemStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798847
- Sponsor's protocol ID
- JIIXR.PMCF.2018.13
- Acronym
- JIIXR
- Status last verified
- Jul 2023
- First submitted
- 27 Nov 2018
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT03798847
- Acronym / sponsor ID
- JIIXR / JIIXR.PMCF.2018.13
- Conditions
- Journey II XR Total Knee System
- Keywords
- Journey II XR Total Knee System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
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 estimate the safety and performance of Journey II XR TKS based on retrospective data.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
Key inclusion criteria (2 listed)
- Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
- The TKA occurred at least 12 weeks prior to enrollment.
Key exclusion criteria (1 listed)
- None
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 XR TKAJourney II XR Total Knee System | Device | – |
Primary outcome
Revision of one or more study device components
Time frame: 12 weeks follow up
Measure of the number of revision cases
10 secondary outcomes
Adverse Events
Time frame: 12 weeks follow up
Health care utilization: Hospitalization
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Time frame: Implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
Time frame: Implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Time frame: Implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
Time frame: Implantation through study completion, approximately 3 years
Quality of Life: EQ-5D-3L
Time frame: Implantation through study completion, approximately 3 years
Quality of Life: KSS
Time frame: Implantation through study completion, approximately 3 years
Return to Work
Time frame: Implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Time frame: Implantation through study completion, approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Journey II XR Total Knee System
Active, not recruitingObservational study
JOURNEY II XR Safety and Effectiveness PMCF
Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Journey II XR Total Knee System, run by Smith & Nephew, Inc. at 12 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 2 inclusion and 1 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Revision of one or more study device components (time frame: 12 weeks follow up). 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 14 Jul 2023.