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

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RECRUITINGNCT04884542

Multigen Plus H Study and AMF TT Cones

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.

Lead sponsor: Limacorporate S.p.a•2 locations•View source on ClinicalTrials.gov

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Contacts

Francesca Citossi

CONTACT

+39 335 164026 francesca.citossi@limacorporate.com

Magalì Mafucci

CONTACT

+39 3316082095 magali.mafucci@limacorporate.com

Sponsors

Lead Sponsor

Limacorporate S.p.a

Collaborators

North American Science Associates Ltd.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 10, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment43

Start dateJan 2022

Last updatedMar 10, 2025

Condition

Arthroplasty, Replacement, Knee

Locations shown

AZ Jan Palfijn Gent

Ghent

Nemocnica Bory - Penta Hospital

Bratislava

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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: May 10, 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.

View ClinicalTrials.gov Terms and Conditions