Status:
ACTIVE_NOT_RECRUITING
Journey II BCS EU Observational Trial
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Degenerative Joint Disease
Eligibility:
All Genders
18-75 years
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT02211794
Start Date
January 1 2014
End Date
June 1 2026
Last Update
January 31 2024
Active Locations (5)
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1
UZ Gent
Ghent, Belgium, 9000
2
University of Modena and Reggio Emilia
Modena, Italy, 41124
3
Sint Maartenskliniek
Nijmegen, Netherlands, 9500
4
Martina Hansens Hospital
Sandvika, Norway