Knee Arthroplasty Clinical Trial
Official title:
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
| 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 |
| Verified date | April 2019 |
| Source | BBraun Medical SAS |
| Contact | François Boillot |
| Phone | 144123357 |
| fboillot[@]hpsj.fr | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.
| 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.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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Groupe hospitalier Paris-St Joseph | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| BBraun Medical SAS |
France,
| 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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