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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02934802
Other study ID # AAG-O-H-1420
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 26, 2016
Est. completion date February 2025

Study information

Verified date April 2019
Source BBraun Medical SAS
Contact François Boillot
Phone 144123357
Email fboillot@hpsj.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient having signed informed consent

- Patients over 18 for which a Total Knee Prosthesis with e.motionĀ® 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


Related Conditions & MeSH terms


Intervention

Device:
Total Knee prothesis e motion PS Pro


Locations

Country Name City State
France Groupe hospitalier Paris-St Joseph Paris

Sponsors (1)

Lead Sponsor Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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