VEGA System® Study in the Total Knee Arthroplasty

NCT ID: NCT02944409

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2025-02-28

Brief Summary

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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

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Conditions

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Knee Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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total knee prothesis VEGA System

total knee replacement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BBraun Medical SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie

Arras, , France

Site Status RECRUITING

Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Remy Nizard

Role: CONTACT

1 49 95 65 65 ext. +33

Facility Contacts

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Bruno Tillie

Role: primary

3 21 60 22 11 ext. +33

Remy Nizard

Role: primary

1 49 95 65 65 ext. +33

Other Identifiers

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AAG-O-H-1511

Identifier Type: -

Identifier Source: org_study_id

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