Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
1 other identifier
observational
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2016
CompletedFirst Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedApril 17, 2019
April 1, 2019
8.7 years
October 14, 2016
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Survival rate at 5 years of the e motion PS Pro
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.
the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty
Interventions
Eligibility Criteria
Patients for which a Total Knee Prosthesis with e.motion® PS Pro was decided by the surgeon
You may qualify if:
- 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
You may not qualify if:
- Active or suspected infection
- Tumor on the concerned knee
- Patient vulnerable and under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe hospitalier Paris-St Joseph
Paris, 75014, France
Study Officials
- PRINCIPAL INVESTIGATOR
François Boillot
Groupe hospitalier Paris-St Joseph
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 17, 2016
Study Start
May 26, 2016
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share