Multigen Plus CCK and AMF TT Cones Follow Up Study

Recruiting now

Conditions studied: Total Knee Arthroplasty, Revision Total Knee Arthroplasty

In brief

This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.

Key facts

Study ID

NCT05314491

Run by

Limacorporate S.p.a

People needed

68

Starts

2022-06-21

Expected to finish

2026-07-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK 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.
• Subjects able to comply with the Study Protocol.

You may not qualify if…

• Age < 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 CCK, as reported in the current Instruction For Use.
• Any clinically significant pathology based on the medical history 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.

Where it is running

• Hospital Senhora da Oliveira in Guimarães — Guimarães, Portugal (enrolling)
• Saints Cyril and Methodius Hospital — Bratislava, Slovakia (enrolling)
• Royal Devon and Exeter Hospital — Exeter, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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