RecruitingNCT04884542

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.

Sponsor

Limacorporate S.p.a

Enrollment

43 participants

Start Date

Jan 19, 2022

Study Type

OBSERVATIONAL

Conditions

Arthroplasty Replacement, Knee

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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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