Journey II CR Total Knee SystemJIICRNCT03885531
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
An observational study of Journey II CR Total Knee System, run by Smith & Nephew, Inc. at 6 sites in United States.
Trial summary
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Journey II CR Total Knee System
- What is being tested?
- Total knee arthroplasty with Journey II CR Total Knee System
- Type of treatment
- Medical device
- How many people
- 586 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Mar 2019to 30 Jun 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.
Who may be able to join
- Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
- The TKA occurred at least 12 weeks prior to enrollment
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37922
OrthoNeuro
New Albany, Ohio, 43054
New York University
New York, New York, 10003
Pikeville Medical Center
Pikeville, Kentucky, 41501
Reno Orthopedic Institute
Reno, Nevada, 89503
Orthopaedic Specialists of Scottsdale
Scottsdale, Arizona, 85255
About this study
Official title: Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
- Conditions
- Journey II CR Total Knee System
- Being tested
- Total knee arthroplasty with Journey II CR Total Knee System
- Keywords
- Journey II CR Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with Journey II CR Total Knee SystemDevice
TKA with Journey II CR Total Knee System
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events reported per ISO 14155 guidelines
Measured: 7 years
Secondary outcomes (11)
Length of hospital stay for primary (index) surgery
Measured: 7 years
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Measured: 7 years
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Measured: upon occurence through 7 years of study duration
Number of rehabilitation sessions
Measured: 7 years
Duration of rehabilitation sessions in weeks
Measured: 7 years
Number and type of outpatient visits
Measured: 7 years
Number of re-operations
Measured: 7 years
Quality of Life as measured by EQ-5D-3L score
The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: 7 years
Patient Pain Level as measured by Knee Society Score (KSS)
Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities.
Measured: 7 years
Number of days before return to work
Measured: 7 years
Number of technical difficulties encountered with the device
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start27 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Journey II CR 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nor Consult
- Responsible party
- Sponsor
- Investigators
- Sandra Navarrete, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885531
- Sponsor's protocol ID
- 2018.19.KNE.JIICR.RET
- Acronym
- JIICR
- Status last verified
- Jan 2024
- First submitted
- 6 Mar 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT03885531
- Acronym / sponsor ID
- JIICR / 2018.19.KNE.JIICR.RET
- Conditions
- Journey II CR Total Knee System
- Keywords
- Journey II CR Total Knee System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nor Consult
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Mar 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 examine the safety and performance of the Journey II CR TKS based on retrospective data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.
Key inclusion criteria (2 listed)
- Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an 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 |
|---|---|---|
| Total knee arthroplasty with Journey II CR Total Knee SystemTKA with Journey II CR Total Knee System | Device | – |
Primary outcome
Number of adverse events reported per ISO 14155 guidelines
Time frame: 7 years
11 secondary outcomes
Length of hospital stay for primary (index) surgery
Time frame: 7 years
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Time frame: 7 years
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery
Time frame: upon occurence through 7 years of study duration
Number of rehabilitation sessions
Time frame: 7 years
Duration of rehabilitation sessions in weeks
Time frame: 7 years
Number and type of outpatient visits
Time frame: 7 years
Number of re-operations
Time frame: 7 years
Quality of Life as measured by EQ-5D-3L score
Time frame: 7 years
Patient Pain Level as measured by Knee Society Score (KSS)
Time frame: 7 years
Number of days before return to work
Time frame: 7 years
Number of technical difficulties encountered with the device
Time frame: 7 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 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Journey II CR Total Knee System
Active, not recruitingObservational study
JOURNEY™ II CR Total Knee System
Osteoarthritis, 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.
Sandra Navarrete study chair
Smith & Nephew, Inc.
6 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 CR Total Knee System, run by Smith & Nephew, Inc. at 6 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Number of adverse events reported per ISO 14155 guidelines (time frame: 7 years). 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 3 Jan 2024.