Knee ArthroplastyNCT02944409
VEGA System® Study in the Total Knee Arthroplasty
An observational study of Knee Arthroplasty, run by BBraun Medical SAS at 2 sites in France.
Trial summary
This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- total knee prothesis VEGA System
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Person for whom a replacement of knee was planed and for whom the surgeon planed to use VEGA System for the Knee Arthroplasty
Who may be able to join
- Patient from 18 to 75 years old
- Patient is able to comply with follow-up requirements including postoperative self-evaluations.
- Patient requires a primary knee replacement.
- Patient has a diagnosis of osteoarthritis
- Patient has intact collateral ligaments.
Who cannot join
- Vulnerable patient under legal protection
- Patients with inflammatory arthritis.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie
Arras, 62012
Bruno Tillie, 3 21 60 22 11 ext. +33
- Not yet recruiting
Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie
Paris, 75 010
Remy Nizard, 1 49 95 65 65 ext. +33
About this study
Official title: Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty
This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components
- Conditions
- Knee Arthroplasty
- Being tested
- total knee prothesis VEGA System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee prothesis VEGA SystemDevice
total knee replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the prosthesis at 5 years
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: needs of revision of at least one of the prosthesis component evaluated 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 posted25 Oct 2016 (estimated)
- Study start1 Jul 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944409
- Sponsor's protocol ID
- AAG-O-H-1511
- Status last verified
- Apr 2019
- First submitted
- 12 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
- Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02944409
- Acronym / sponsor ID
- AAG-O-H-1511
- Conditions
- Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 25 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 long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Person for whom a replacement of knee was planed and for whom the surgeon planed to use VEGA System for the Knee Arthroplasty
Key inclusion criteria (5 listed)
- Patient from 18 to 75 years old
- Patient is able to comply with follow-up requirements including postoperative self-evaluations.
- Patient requires a primary knee replacement.
- Patient has a diagnosis of osteoarthritis
- Patient has intact collateral ligaments.
Key exclusion criteria (4 listed)
- Vulnerable patient under legal protection
- Patients with inflammatory arthritis.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Pregnancy
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 VEGA Systemtotal knee replacement | Device | – |
Primary outcome
Survival rate of the prosthesis at 5 years
Time frame: needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty
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
Related trials for Knee Arthroplasty
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Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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Enrolling by invitation
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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.
2 sites 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 2 sites 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 5 inclusion and 4 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 2 sites 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 Remy Nizard (1 49 95 65 65 ext. +33, remy.nizard@lrb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of the prosthesis at 5 years (time frame: needs of revision of at least one of the prosthesis component evaluated 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.