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Multicentre GMK UNI Anatomical Cementless Study - FR

NCT ID: NCT06715917

Last Updated: 2024-12-16

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

ACTIVE_NOT_RECRUITING

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-06

Study Completion Date

2032-03-06

Brief Summary

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Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.

Detailed Description

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Conditions

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Osteoarthritis of the Knee Avascular Necrosis of the Femoral Condyle Revision Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
* Patient's age between 18 and 75 years old;
* Patients must be willing to comply with the pre and postoperative evaluation schedule.

* Patients aged under 18 years;
* Patients aged over 75 years;

Exclusion Criteria

* Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery
* Patients unable to understand and take action;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Saint Vincent de Paul

Bourgoin, , France

Site Status

Polyclinique du Parc

Caen, , France

Site Status

Clinique du Mail

La Rochelle, , France

Site Status

Centre Orthéo

Saint-Etienne, , France

Site Status

Bürgerspital Solothurn

Solothurn, , Switzerland

Site Status

Countries

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France Switzerland

Other Identifiers

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P02.018.02

Identifier Type: -

Identifier Source: org_study_id