VEGA System® Study in the Total Knee Arthroplasty

NCT02944409 | Unknown

• 1 other identifier: AAG-O-H-1511
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

  needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty

Interventions

total knee prothesis VEGA System DEVICE

total knee replacement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (2)

Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie

Arras, 62012, France

RECRUITING

Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie

Paris, 75 010, France

NOT YET RECRUITING

Central Study Contacts

Remy Nizard

CONTACT

1 49 95 65 65; remy.nizard@lrb.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 25, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)