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Multigen Plus H Study and AMF TT Cones | Clinical Trials | Clareo Health

RECRUITING

Multigen Plus H Study and AMF TT Cones

A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H Alone or Involving AMF TT Cones.

NCT04884542•Limacorporate S.p.a

View on ClinicalTrials.gov

Summary

The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female
•Age ≥ 18 years old
•Given written informed consent approved by the reference Ethics Committee (EC)
•Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
•Subject is able to comply with the protocol

Exclusion Criteria

•Age \&lt; 18 years old
•Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
•Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
•Female subjects who are pregnant, nursing, or planning a pregnancy
•Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \< 70 points.

Locations (2)

AZ Jan Palfijn Gent

Ghent, Belgium

Nemocnica Bory - Penta Hospital

Bratislava, Slovakia

Key Dates

Start Date

January 19, 2022

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

March 10, 2025

Enrollment

ESTIMATED participants

Conditions

Arthroplasty, Replacement, Knee

Interventions

Revision Total Knee Arthroplasty

DEVICE

Contacts

Francesca Citossi

CONTACT

+39 335 164026 francesca.citossi@limacorporate.com

Magalì Mafucci

CONTACT

+39 3316082095 magali.mafucci@limacorporate.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multigen Plus H Study and AMF TT Cones

Inclusion Criteria

Exclusion Criteria

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