Status:
RECRUITING
Multigen Plus CCK and AMF TT Cones Follow Up Study
Lead Sponsor:
Limacorporate S.p.a
Conditions:
Total Knee Arthroplasty
Revision Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Brief Summary
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), alon...
Detailed Description
This is a post-market, multicentric, prospective, open label study. It is a post-marketing clinical study because the investigational devices are registered, CE marked, and used according to the inten...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05314491
Start Date
June 21 2022
End Date
July 1 2026
Last Update
March 10 2025
Active Locations (3)
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1
Hospital Senhora da Oliveira in Guimarães
Guimarães, Portugal
2
Saints Cyril and Methodius Hospital
Bratislava, Slovakia
3
Royal Devon and Exeter Hospital
Exeter, United Kingdom