Phase
Condition
N/ATreatment
Revision Total Knee Arthroplasty
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 KneeArthroplasty with the Multigen Plus H system as per Indication For Use. The decisionto implant a Multigen Plus H system, alone or involving the AMF TT cones, must betaken prior to, and independently from, the decision to enrol the subject. Thisdecision should be made in accordance with routine clinical practice at the studysite concerned.
Subject is able to comply with the protocol
Exclusion
Exclusion Criteria:
Age < 18 years old
Subjects with any Multigen Plus system contraindication for use, or any AMF TT conescontraindication for use when used in combination with the Multigen Plus H, asreported in the current Instruction For Use.
Any clinically significant pathology based on the medical history or any medicalintervention 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 whoseoutcome is achieving an KSS < 70 points.
Study Design
Connect with a study center
AZ Jan Palfijn Gent
Gand, 9000
BelgiumActive - Recruiting
Nemocnica Bory - Penta Hospital
Bratislava, 625J+3P
SlovakiaSite Not Available
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