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.

Limacorporate S.p.a2 sites in 2 countries43 target enrollmentJanuary 19, 2022

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: N/A
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Limacorporate S.p.a
Enrollment: 43
Locations: 2
Primary Endpoint: Functional Knee Society Score (KSS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 19, 2022

End Date

June 30, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

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.