Journey II BCS EU Observational Trial

Study Overview
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Brief Summary
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Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Detailed Description
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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.

Official Title
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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

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Other: data collection


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 cohort<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | pre-op, 3month, 1yr, 2yr, 5yr, 10yr | 
| Knee Pain Evaluation Form questionnaire | Assessment of post-operative knee pain | 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 | 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. | pre-op, discharge, 3month, 1yr, 5yr, 10yr | 
| complication rate (adverse events and revisions) | complications will be assessed at each visit. | discharge, 3month, 1yr, 2yr, 5yr, 10yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, degenerative joint disease