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VEGA System® Study in the Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02944409
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
BBraun Medical SAS

Brief 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

Condition or disease Intervention/treatment
Knee Arthroplasty Device: total knee prothesis VEGA System

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources


Intervention Details:
    Device: total knee prothesis VEGA System
    total knee replacement


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria

  1. Patient from 18 to 75 years old
  2. Patient is able to comply with follow-up requirements including postoperative self-evaluations.
  3. Patient requires a primary knee replacement.
  4. Patient has a diagnosis of osteoarthritis
  5. Patient has intact collateral ligaments.

Exclusion Criteria

  1. Vulnerable patient under legal protection
  2. Patients with inflammatory arthritis.
  3. Patients that have had a high tibial osteotomy or femoral osteotomy.
  4. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944409


Contacts
Contact: Remy Nizard 1 49 95 65 65 ext +33 remy.nizard@lrb.aphp.fr

Locations
France
Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie Recruiting
Arras, France, 62012
Contact: Bruno Tillie    3 21 60 22 11 ext +33      
Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie Not yet recruiting
Paris, France, 75 010
Contact: Remy Nizard    1 49 95 65 65 ext +33      
Sponsors and Collaborators
BBraun Medical SAS

Responsible Party: BBraun Medical SAS
ClinicalTrials.gov Identifier: NCT02944409     History of Changes
Other Study ID Numbers: AAG-O-H-1511
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No