VEGA System® Study in the Total Knee Arthroplasty | NCT02944409

Studies
VEGA System® Study in the Total Knee Arthroplasty

NCT02944409

Sponsor

BBraun Medical SAS

Status

Unknown status

Last Update Posted

Apr 17, 2019Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Knee Arthroplasty

Interventions

total knee prothesis VEGA System

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Feb 2025Estimated

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 24, 2016

First Posted Date

Oct 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
total knee prothesis VEGA System	Device	total knee replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Remy Nizard	Contact	1 49 95 65 65	+33	remy.nizard@lrb.aphp.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie	Recruiting	Arras		62012	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided