Trials / Active Not Recruiting
Active Not RecruitingNCT02211794
Journey II BCS EU Observational Trial
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 175 (actual)
- Sponsor
- Smith & Nephew Orthopaedics AG · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | data collection |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2014-08-07
- Last updated
- 2024-01-31
Locations
5 sites across 5 countries: Belgium, Italy, Netherlands, Norway, United Kingdom
Source: ClinicalTrials.gov record NCT02211794. Inclusion in this directory is not an endorsement.