Journey II BCS EU Observational Trial
Study Details
Study Description
Brief Summary
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Other: data collection
|
Outcome Measures
Primary Outcome Measures
- Revision for any reason [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.
Secondary Outcome Measures
- EQ-5D questionnaire [pre-op, 3month, 1yr, 2yr, 5yr, 10yr]
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)
- Knee Pain Evaluation Form questionnaire [3month, 1yr, 2yr]
Assessment of post-operative knee pain
- 2011 Knee Society Score [pre-op, 3month, 1yr, 2yr, 5yr, 10yr]
A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome
- radiographic evaluation [pre-op, discharge, 3month, 1yr, 5yr, 10yr]
The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.
- complication rate (adverse events and revisions) [discharge, 3month, 1yr, 2yr, 5yr, 10yr]
complications will be assessed at each visit.
Eligibility Criteria
Criteria
Inclusion Criteria
-
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
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Gent | Gent | Belgium | 9000 | |
| 2 | University of Modena and Reggio Emilia | Modena | Italy | 41124 | |
| 3 | Sint Maartenskliniek | Nijmegen | Netherlands | 9500 | |
| 4 | Martina Hansens Hospital | Sandvika | Norway | ||
| 5 | North Hampshire Hospital | Basingstoke | United Kingdom | RG24 7AL |
Sponsors and Collaborators
- Smith & Nephew Orthopaedics AG
Investigators
- Principal Investigator: Mike Risebury, MD, North Hampshire Hospital
- Study Chair: Fabio Catani, Prof, University of Modena and Reggio Emilia
- Principal Investigator: Jan Victor, Prof, UZ Ghent
- Principal Investigator: Gijs Van Hellemondt, Sint-Maartenskliniek Nijmegen
- Principal Investigator: Stig Heir, Martina Hansens Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R11009-7