Degenerative Joint DiseaseNCT02211794
Journey II BCS EU Observational Trial
An observational study of Degenerative Joint Disease, run by Smith & Nephew Orthopaedics AG at 5 sites in 5 countries.
Trial summary
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- data collection
- How many people
- 179 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 5 Feb 2014to Oct 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a patient population consisting of 150 cases and recruited from 4 different countries, will be followed up when undergoing TKA as part of their standard care
Who may be able to join
- subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
- subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
- subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form
Who cannot join
- age > 75 years
- conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- subject has inadequate bone stock to support the device
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
Read the detailed description
Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).
Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.
- Conditions
- Degenerative Joint Disease
- Being tested
- data collection
- Keywords
- Total Knee Arthroplasty, degenerative joint disease
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| 1 cohort | subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision for any reason
The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.
Measured: 10Years
Secondary outcomes (5)
EQ-5D questionnaire
patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)
Measured: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
Knee Pain Evaluation Form questionnaire
Assessment of post-operative knee pain
Measured: 3month, 1yr, 2yr
2011 Knee Society Score
A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome
Measured: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
radiographic evaluation
The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.
Measured: pre-op, discharge, 3month, 1yr, 5yr, 10yr
complication rate (adverse events and revisions)
complications will be assessed at each visit.
Measured: discharge, 3month, 1yr, 2yr, 5yr, 10yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study start5 Feb 2014
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Risebury, MD, Principal investigator, North Hampshire HospitalFabio Catani, Prof, Principal investigator, University of Modena and Reggio EmiliaJan Victor, Prof, Principal investigator, UZ GhentGijs Van Hellemondt, MD, Principal investigator, Sint-Maartenskliniek NijmegenStig Heir, MD, Principal investigator, Martina Hansens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211794
- Sponsor's protocol ID
- R11009-7
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2014
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BSI Publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System
- ClinicalTrials.gov ID
- NCT02211794
- Acronym / sponsor ID
- R11009-7
- Conditions
- Degenerative Joint Disease
- Keywords
- Total Knee Arthroplasty, degenerative joint disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Aug 2014 (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.
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
Detailed description
Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).
Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 cohort | – | Other: data collectionsubject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a patient population consisting of 150 cases and recruited from 4 different countries, will be followed up when undergoing TKA as part of their standard care
Key inclusion criteria (3 listed)
- subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
- subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
- subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form
Key exclusion criteria (3 listed)
- age > 75 years
- conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- subject has inadequate bone stock to support the device
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 |
|---|---|---|
| data collection | Other | 1 cohort |
Primary outcome
Revision for any reason
Time frame: 10Years
The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.
5 secondary outcomes
EQ-5D questionnaire
Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
Knee Pain Evaluation Form questionnaire
Time frame: 3month, 1yr, 2yr
2011 Knee Society Score
Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
radiographic evaluation
Time frame: pre-op, discharge, 3month, 1yr, 5yr, 10yr
complication rate (adverse events and revisions)
Time frame: discharge, 3month, 1yr, 2yr, 5yr, 10yr
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 25 Sep 2026.
- Individual participant dataSharing planned: Yes. BSI Publication
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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.
Mike Risebury, MD principal investigator
North Hampshire Hospital
Fabio Catani, Prof principal investigator
University of Modena and Reggio Emilia
Jan Victor, Prof principal investigator
UZ Ghent
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease, run by Smith & Nephew Orthopaedics AG at 5 sites in 5 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 3 inclusion and 3 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Italy, Netherlands, Norway, United Kingdom. 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?
Revision for any reason (time frame: 10Years). 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 25 Sep 2026.