Osteoarthritis, KneeNCT02440672
JOURNEY™ II CR Total Knee System
An observational study of Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 9 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- JOURNEY™ II CR Total Knee System (J II CR TKS)
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Sep 2015to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who present with DJD of the knee will be screened to determine if they meet all inclusion and no exclusion criteria. If all entry criteria are achieved, the subject will be eligible to participate in the study. All general and indication-specific entry criteria must be met prior to study entry.
Who may be able to join
- Subjects MUST meet ALL of the following criteria for inclusion in the study:
- Has signed the IRB/EC approved ICF specific to this study prior to study participation
- Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
- Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:
- Post-traumatic arthritis
- Osteoarthritis
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- Degenerative arthritis
- Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
- Is in general good health (as determined by the Investigator) based on screening assessments and medical history
- Is independent, ambulatory, and can comply with all post-operative evaluations
- plans to be available through ten (10) years post-operative follow-up
Who cannot join
- 1. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- Any of the following conditions in the index joint:
- does not require patella resurfacing
- has received a TKA or unicondylar arthroplasty
- has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis)
- Any of the following conditions in the contralateral joint:
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- has enrolled in the study for the contralateral knee
- has received TKA as a revision for a failed total or unicondylar knee arthroplasty
- has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator
- Any of the following conditions of the hip:
- received contralateral or ipsilateral revision hip arthroplasty
- has ipsilateral hip arthritis resulting in flexion contracture
- has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator
- Has diagnosis of an immunosuppressive disorder
- Has presence of malignant tumor, metastatic, or neoplastic disease
- Has family history of severe osteoporosis/osteopenia
- Has a known allergy to study device or one or more of its components
- Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- Is receiving medication for the diagnosis of fibromyalgia
- has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
- Is pregnant or plans to become pregnant during the study
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator
- Has a BMI > 40
- Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment
- Is currently involved in personal injury litigation or a worker's compensation claim
- Is facing current or impending incarceration
- Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States6 sites
Anne Arundel Health System Research Institute, Inc
Annapolis, Maryland, 21401
Rush University Medical Center
Chicago, Illinois, 60612
The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
Cincinnati, Ohio, 45219
Center for Hip and Knee Replacement at Columbia University Medical Center
New York, New York, 10032
Orthopedic Institute of the West
Phoenix, Arizona, 85054
Wake Forest University
Winston-Salem, North Carolina, 27157
United Kingdom2 sites
Royal National Orthopaedic Hospital NHS Trust
Stanmore
Barts Health NHS Trust
Whitechapel
Spain1 site
Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
Barcelona
About this study
Official title: A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System
The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
Read the detailed description
This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.
- Conditions
- Osteoarthritis, Knee
- Being tested
- JOURNEY™ II CR Total Knee System (J II CR TKS)
- Keywords
- Osteoarthritis, TKA, Degenerative Knee Disease
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOURNEY™ II CR Total Knee System (J II CR TKS)Device
Also called JOURNEY™ II CR, (J II CR TKS)
TKA with Journey II CR Total Knee System
| Study group | Role | What they receive |
|---|---|---|
| Device:JOURNEY™ II CR Total Knee System (J II CR TKS) | Subjects having TKA with JOURNEY™ II CR Total Knee System Receives: Device: JOURNEY™ II CR Total Knee System (J II CR TKS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM
Measured: 1 year post-op analysis
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
Measured: Up to 10 year post-operative analysis
Secondary outcomes (10)
Clinical Outcomes: EuroQol 5D (EQ-5D) scale
Measured: Pre-Op to 10 yrs
Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation
Measured: Pre-Op to 10 yrs
Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS
Measured: Pre-Op to 10 yrs
Health Economic Endpoints : Physical therapy visit quantification/duration
Measured: 30, 60, and 90-day hospital re-admission rate
Health Economic Endpoints: Discharge destination(s)/length of stay
Measured: 30, 60, and 90 days
Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician)
Measured: 30, 60, and 90 days
Health Economic Endpoints: Concomitant medications/procedures associated with the knee
Measured: 30, 60, and 90 days
Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment.
Measured: Pre-Op to 10 yrs
Safety Endpoints: Manipulations under anesthesia
Measured: Pre-Op to 10 yrs
Safety Endpoints: Radiographic analysis
Measured: Pre-Op to 10 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keji Alao, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440672
- Sponsor's protocol ID
- 13-4049-06
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System
- ClinicalTrials.gov ID
- NCT02440672
- Acronym / sponsor ID
- 13-4049-06
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, TKA, Degenerative Knee Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 May 2015 (estimated)
- 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 purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
Detailed description
This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device:JOURNEY™ II CR Total Knee System (J II CR TKS) | – | Device: JOURNEY™ II CR Total Knee System (J II CR TKS)Subjects having TKA with JOURNEY™ II CR Total Knee System |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who present with DJD of the knee will be screened to determine if they meet all inclusion and no exclusion criteria. If all entry criteria are achieved, the subject will be eligible to participate in the study. All general and indication-specific entry criteria must be met prior to study entry.
Key inclusion criteria (11 listed)
- Has signed the IRB/EC approved ICF specific to this study prior to study participation
- Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
- Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:
- Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
- Is in general good health (as determined by the Investigator) based on screening assessments and medical history
Key exclusion criteria (27 listed)
- 1. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- Any of the following conditions in the index joint:
- Any of the following conditions in the contralateral joint:
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 CR Total Knee System (J II CR TKS)Also: JOURNEY™ II CR, (J II CR TKS)TKA with Journey II CR Total Knee System | Device | Device:JOURNEY™ II CR Total Knee System (J II CR TKS) |
Primary outcome
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM
Time frame: 1 year post-op analysis
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
Time frame: Up to 10 year post-operative analysis
10 secondary outcomes
Clinical Outcomes: EuroQol 5D (EQ-5D) scale
Time frame: Pre-Op to 10 yrs
Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation
Time frame: Pre-Op to 10 yrs
Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS
Time frame: Pre-Op to 10 yrs
Health Economic Endpoints : Physical therapy visit quantification/duration
Time frame: 30, 60, and 90-day hospital re-admission rate
Health Economic Endpoints: Discharge destination(s)/length of stay
Time frame: 30, 60, and 90 days
Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician)
Time frame: 30, 60, and 90 days
Health Economic Endpoints: Concomitant medications/procedures associated with the knee
Time frame: 30, 60, and 90 days
Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment.
Time frame: Pre-Op to 10 yrs
Safety Endpoints: Manipulations under anesthesia
Time frame: Pre-Op to 10 yrs
Safety Endpoints: Radiographic analysis
Time frame: Pre-Op to 10 yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Keji Alao study chair
Smith & Nephew, Inc.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 9 sites in 3 countries.
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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 12 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 9 sites in United States, United Kingdom, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM (time frame: 1 year post-op analysis). The study lists 2 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 12 Jun 2026.