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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Joint Disease
- Sponsor
- Smith & Nephew Orthopaedics AG
- Enrollment
- 175
- Locations
- 5
- Primary Endpoint
- Revision for any reason
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- complication rate (adverse events and revisions)(discharge, 3month, 1yr, 2yr, 5yr, 10yr)
- 2011 Knee Society Score(pre-op, 3month, 1yr, 2yr, 5yr, 10yr)
- radiographic evaluation(pre-op, discharge, 3month, 1yr, 5yr, 10yr)
- EQ-5D questionnaire(pre-op, 3month, 1yr, 2yr, 5yr, 10yr)
- Knee Pain Evaluation Form questionnaire(3month, 1yr, 2yr)