Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
Recruiting
- Conditions
- Knee Arthroplasty
- Registration Number
- NCT02934802
- Lead Sponsor
- BBraun Medical SAS
- Brief Summary
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- Patient having signed informed consent
- Patients over 18 for which a Total Knee Prosthesis with e.motion® PS Pro was decided
- Patients willing to participate in a 5 years follow-up
Exclusion Criteria
- Active or suspected infection
- Tumor on the concerned knee
- Patient vulnerable and under legal protection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival rate at 5 years of the e motion PS Pro the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty The endpoint is the revision of at least one of the prosthesis components. If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Groupe hospitalier Paris-St Joseph
🇫🇷Paris, France