Knee ArthroplastyNCT02934802
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
An observational study of Knee Arthroplasty, run by BBraun Medical SAS at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Total Knee prothesis e motion PS Pro
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2016to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for which a Total Knee Prosthesis with e.motion® PS Pro was decided by the surgeon
Who may be able to join
- 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
Who cannot join
- Active or suspected infection
- Tumor on the concerned knee
- Patient vulnerable and under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe hospitalier Paris-St Joseph
Paris, 75014
François BOILLOT, fboillot@hpsj.fr
About this study
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.
- Conditions
- Knee Arthroplasty
- Being tested
- Total Knee prothesis e motion PS Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee prothesis e motion PS ProDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start26 May 2016
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Boillot, Principal investigator, Groupe hospitalier Paris-St Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934802
- Sponsor's protocol ID
- AAG-O-H-1420
- Status last verified
- Apr 2019
- First submitted
- 14 Oct 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
- ClinicalTrials.gov ID
- NCT02934802
- Acronym / sponsor ID
- AAG-O-H-1420
- Conditions
- Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 26 May 2016 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for which a Total Knee Prosthesis with e.motion® PS Pro was decided by the surgeon
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Active or suspected infection
- Tumor on the concerned knee
- Patient vulnerable and under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee prothesis e motion PS Pro | Device | – |
Primary outcome
Survival rate at 5 years of the e motion PS Pro
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Boillot principal investigator
Groupe hospitalier Paris-St Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, run by BBraun Medical SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Boillot (144123357 ext. +33, fboillot@hpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate at 5 years of the e motion PS Pro (time frame: the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.