Multigen Plus CCK and AMF TT Cones Follow Up Study

Launched by LIMACORPORATE S.P.A · Mar 30, 2022

Keywords

ClinConnect Summary

The Multigen Plus CCK and AMF TT Cones Follow Up Study is looking at a specific type of knee replacement surgery called Total Knee Arthroplasty (TKA). This research involves evaluating how well the Multigen Plus CCK system works for patients with knee joint issues, such as instability or weak ligaments. The study will include 68 participants who are undergoing either primary knee replacement or a revision of a previous knee replacement, allowing doctors to assess both the clinical outcomes and the imaging results of this treatment.

To participate in this trial, individuals need to be at least 18 years old and have already been advised to have the Multigen Plus knee replacement. They should be able to follow the study's guidelines and provide consent. However, some people may not be eligible, such as those under 18, those with certain medical conditions, or women who are pregnant or nursing. Participants in the trial can expect to undergo standard procedures related to their knee replacement, and their progress will be monitored closely to gather important information about the effectiveness of this surgical approach.

Gender

ALL

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 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.
• Exclusion Criteria:
• • 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.